PROCEEDINGS [8:55 a.m.]

Agenda Item: Call to Order – Dr. Cohn

DR. COHN: We’re going to get started here in just a minute, would everyone
please be seated? Okay, good morning, I want to call this meeting to order.
This is the second day of two days of hearings of the Subcommittee on Standards
and Security of the National Committee on Vital and Health Statistics. The
committee is the main public advisory committee to the U.S. Department of
Health and Human Services on national health information policy. Obviously I
also want to mention for those of you in attendance that there is actually a
full meeting of the committee scheduled for tomorrow, so you’re obviously
welcome for that also.

My name is Simon Cohn, I am the national director for health information
policy for Kaiser Permanente and chair of the committee, and I apologize, I
seem to have a frog in my throat here. I want to welcome fellow subcommittee
members, HHS, and others here in person. I also want to welcome those listening
in on the internet, and of course as always I want to remind everyone in the
room to make sure to speak into the microphone and speak clearly so those on
the internet can hear us in our deliberations today.

Obviously there’s a lot to cover today. This morning we begin with a HIPAA
update and we’re pleased to have Karen Trudel here sort of telling us a little
bit about implementation as well as recent developments for HIPAA. That will be
followed by a discussion on the claims attachment work and sort of a discussion
really of what should be the next steps for the committee, I think we had
drafted a letter but really the question for the subcommittee is whether we’re
ready to move forward with a letter or whether we need to do further
investigations and discussions with the industry and public before we move
forward with a letter at this point.

Following that and after our morning break is a discussion with the dental
community. The focus of that session is really on SNODENT and whether it is
appropriate to recommend SNODENT as a clinical terminology for dentistry, an
issue as you remember was sort of still open from our PMRI deliberations from
last year. But having reviewed some of the testimony I think we’re all aware
that there are other issues that are going to be coming before the subcommittee
in terms of just general discussions around coding issues and the dental
community.

After lunch we will further discuss our role in investigating and
recommending e-prescribing standards. As many of you know the recently approved
Medicare Reform legislation, otherwise known as DIMA(?), calls on the Secretary
to adopt standards for e-prescribing and the NCVHS has been directed to develop
such standards recommendations. Jim Scanlon and Karen Trudel will update us on
the department DIMA(?) work plan, and then we’ll be discussing a draft work
plan for our work, which I think we’ll be reflecting on in our meetings with
the full committee tomorrow. Obviously I want to thank Jeff Blair, our vice
chair, for his work in terms of putting together I think an excellent draft
work plan for us to use in discussion.

Obviously I want to emphasize that this is an open session, those in
attendance are welcome to make brief remarks on topics, on issues pertinent to
our discussions. We will also have time at the end of each session for brief
comment by those in attendance. Finally, for those on the internet we welcome
email and letter comments on issues coming before the subcommittee.

With that let’s have introductions around the table and around the room.
For those on the national committee I would ask if there are any issues coming
before us today for which you need to publicly recuse yourself. Jeff?

MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the
subcommittee, a member of AMIA, ASTM, HL7, HIMSS, and there’s nothing on the
agenda for today that I’m aware of that I would need to recuse myself.

DR. HUFF: Stan Huff with Intermountain Health Care and the University of
Utah in Salt Lake City. I would need to recuse myself if we talk about HL7,
LOINC, or ICD-10-PCS.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the
committee and subcommittee.

MS. GREENBERG: Marjorie Greenberg from the National Center for Health
Statistics, CDC, and executive secretary to the committee.

DR. COHN: With that, Karen, welcome, Happy New Year, and thank you for
coming to join us and talk about HIPAA and where we are.

Agenda Item: HIPAA Update – Ms. Trudel

MS. TRUDEL: Thank you. I’m going to take just a few minutes to do a brief
update on compliance, complaints, regulations in general, and then spend the
rest of the time doing a brief overview of the National Provider Identifier
final rule, which was published on the 23rd of January. And I’m
sorry, Pat Payton, who’s the chief author of that document, was not able to
come down and do the presentation because of some road conditions up in
Baltimore, but I really kind of wanted her to hear some of those applause also.

Let’s start with compliance and complaints. The Medicare compliance rate is
slowly rising, it’s just above 60 percent at this point, and what we’re hearing
from other health plans is again, that there is a slow but steady increase in
the rate of compliance for claims.

In terms of complaints we’ve received much fewer then what OCR has at this
point on their plate, we have a total of 46 complaints, only 35 of which turned
out to relate to transactions and code sets, some of the others were privacy,
which were forwarded to OCR, or others that were outside our legal scope.

Of the 35 actual transaction and code set complaints 27 of them had to do
with complaints that a compliant claim had been rejected by a health plan. Two
had to do with companion guide issues where there were allegations that
companion guide requirements were in conflict with the implementation guides in
the standards. We have five code set issues to resolve, and one issue that has
to do with the NCPDP retail pharmacy format. About 48 percent of all of the
complaints that do relate to transactions and code sets, the complainants
indicated that there was some sort of a cash flow implication that caused them
to file the complaint in the first place.

The vast majority of the complaints we received are from small providers
filing complaints against health plans. And at this point we have taken in
every complaint, we have sent a letter to the covered entity complained against
asking them for information, have they fixed the problem, do they have a
corrective action plan, and all of them have been responsive to date. We found
that we are able to work out many of the issues, changes are being made, and at
this point we have not had to go any further then exchanging information and
working towards voluntary compliance, which is exactly what we had been hoping
for.

So that is the status on our complaints.

Let me talk a little bit now about the National Provider Identifier. The
final rule was published on January 23rd, the effective date is May
23rd, 2005. Let me explain why that is. We normally don’t have an
effective date that is that far out. The reason for that is that we want to
make sure that providers who are covered entities can begin to apply for NPIs
as of the effective date which gives them the full two years after that to do
whatever implementation work they have and also the same for health plans. And
we don’t that the system for providing enumeration and the contractor who will
handle that enumeration process would be in place until next May.

The compliance dates are May 23rd, 2007, for everyone except
small health plans, and May 23rd, 2008, for small health plans. And
by these dates covered entities must use only the NPI to identify providers in
standard transactions.

There was a lot of discussion about what a National Provider Identifier
should and should not do, and I apologize for those of you can see these, I’m
almost reading the slides, but I’m sure you can’t see them on the internet. The
NPI will replace legacy provider identifiers, including the UPIN, any other
provider IDs that health plans give out, and it will simply transactions, and
save money in the long term because everyone will be able to identify a
provider in the same way.

The possession of an NPI will not guarantee reimbursement by health plans
to that provider, it will not enroll providers in health plans, it won’t make a
provider a covered entity if it isn’t a covered entity. And it will not require
providers to conduct electronic transactions.

It’s important to note that a lot of the comments we received on the
proposed rule had to do with making the NPI more robust in terms of collecting
data. The feedback that we got was that an enumeration system could be bare
bones in terms of data because health plans were still going to have enrollment
processes, and those enrollment processes were going to be much more robust,
they would require additional information, they would require additional
assessment on behalf of the plan and therefore we didn’t need to collect that
data twice. Also simplifies keeping the data up to date.

So what does the NPI look like? We started out with an eight position
alphanumeric, in the final rule we went to a ten position all numeric with
nine, with the tenth being the check digit. It still does not convey any
information about the provider and it is compatible with health insurance card
issuer standards.

Who can have an NPI? The regulation says that any health care provider can
have one, covered and non-covered, individuals, organizations, and indeed
subparts of providers. The issue of subparts is a legal one because a provider
by definition is a legal entity, sometimes a subpart is not a legal entity but
it furnishes health care in a very separate way. For instance, a nursing home
chain may be one legal entity but each of the nursing homes within it provide
care and billing is done on an individual basis. Each one of those would need a
provider ID but the chain itself would be the legal unit. The concept doesn’t
necessarily correlate to the hybrid entities in the privacy rule but it does
allow us to assign provider IDs at a level that’s consistent with business
needs. This concept of a subpart obviously doesn’t apply to individuals.

A covered provider is responsible for determining whether its subparts need
NPIs, and the covered provider is responsible for either obtaining it or making
sure that the subpart does so. And the covered provider is responsible for any
subparts compliance with the final rule.

So how does a provider get an NPI? It’s important to note, and I’ll note it
again, that providers are not going to have to do anything for quite a while,
obviously the system won’t even be available to provide the identifiers for
another year plus. But when the system is available the provider would complete
an application form, we will provide for electronic filing, the application
would be processed, data would be edited, validated, we would be looking for
potential duplicate applications. And then the provider would receive a
notification of what their NPI is. We hope to do as much of this electronically
as we possibly can.

The information that we will collect will be used to make sure that we are
uniquely identifying the provider, that we are not providing a duplicate ID or
mixing up two providers, and also will be collecting necessary information so
that we can communicate with that provider. So we’re asking for addresses,
we’re asking for birth date name, information that we will use to either check
against the database to see if there’s already one there, or to make sure that
we can communicate back with the provider and say this is what your NPI is. We
will be collecting somewhat different information obviously for individuals and
organizations and we’ve categorized the information as being either required,
situational, or optional.

Required information for individuals would be name, gender, address and
telephone, the taxonomy code which is what their specialty is, date of birth,
state/country of birth, contact person’s name and telephone number. Situational
would be state licensing numbers. Optional will be things like the Social
Security Number or Tax ID, other names, credentials, other identifiers.

About organizations we will require similar information, the contact
information, authorized officials name. For situational elements the employer
identification number if the provider has one. Again, license numbers, if the
provider is of a certain type, and optional again, other names or identifiers.

The system itself will be developed under contract with HHS/CMS. It will
process the applications, assign the NPIs, it will store the information about
enumerated providers. It will apply updates because providers are required to
maintain their information and update it as it changes. It can generate reports
and statistics, and we do have a system of records notice on file.

The enumerator, whatever organization will run this system and actually
issue the identifiers, again will operate under one contract, it will receive
the applications and the updates, resolve errors, help with problems, handle
data requests, and it will use the national provider system as its tool to do
that.

Again, important to note, providers don’t have to do anything now. By May
of 2005 covered providers will be able to begin to apply for NPIs, we expect
extremely heavy initial demand. And the covered providers must begin using
their NPIs in standard transactions within two years. Non-covered providers may
also apply for NPIs as we said before, having one does not make you a covered
entity. There’s no requirement for non-covered providers to obtain them or use
them, and it’s perfect okay for NPIs to be used on paper transactions as well.
And in fact we expect that health plans will do this as a matter of
administrative simplicity.

In terms of disseminating data we’ve specified three levels of users, one
of which is HHS and the enumerator, those entities would have access to all the
data, the health industry, which need enough data to be able to match up the
new NPIs with their existing provider base, and the general public. And the
amount of data that we would be willing to disseminate to those groups is
smaller. Again, we do expect that we will have an initial demand for data in
addition to demand for identifiers, and we will protect confidentiality of that
data based on our systems of records notice and an output strategy, a data
publication strategy is still to be determined and published.

So what are some of the changes from the proposed rule? I think these will
not surprise you and in fact I think the NCVHS made a lot of these
recommendations. That the NCI be ten position all numeric instead of eight
alphanumeric. That there be a single enumerator. That we distinguish between
individuals and organizations but would no longer have a separate category for
groups. The NPS is collecting less data about providers then initially
proposed. And that there be three levels of data dissemination instead of two.
Some of the data that fell away when we went to this leaner and meaner approach
is race ethnicity, birth country name I believe that is, education information,
certification number, all practice locations, membership in groups, and
organization type control code.

Some new data is primarily administrative, contact person, a reactivation
date if the NPI is closed and then reopened for some reason, maybe the person
stops practicing and then starts again, very little additional data.

I’ll skip over this, this is just where the different items can be found in
the final rule.

The provider requirements are to obtain an NPI, to use it to identify the
provider, to disclose it when requested, furnish updates to the national
provider system within 30 days of a change, that if your address changes in a
month while you’re telling the post office you tell the NPS as well. We require
business associates to use all NPIs appropriately, and to comply with the
requirements for subparts.

Requirements for health plans and clearinghouses, the plans must use NPIs
on transactions, may not require enumerated providers to obtain more NPIs. The
health care clearinghouses must use NPIs to identify providers on standard
transactions so that basically a health plan may crosswalk its existing
provider identification scheme within its own walls and systems, but when it
sends transactions and when it receives transactions they must use the NPI.

So what should covered entities be doing right now? Becoming informed is
one of the few things that providers need to do right now. Health plans need to
begin to look at their own processes and systems that are effected by provider
identifiers. Hospitals, for instance, that need to report physician identifiers
on claims need to begin to look at how they’re going to crosswalk and update
those identifiers. Develop implementation plans with trading partners and
educate staff.

We talked about the effect on providers. The effect on health plans is
definitely more significant then for providers, the provider will just view the
one identifier. Legacy and health plan assigned provider identifiers will not
be permitted, so that the plan will need to crosswalk those with the NPI.
There’s no information about the provider existing in the NPI, in other words
there is no intelligence in the number, a number of plans have assigned
provider identifiers so that if it has a first digit it means it’s a hospital
or it’s in XY county, there needs to be some planning and some thought about
how to crosswalk those to this new no intelligence rule. It should simplify
coordination of benefits considerably and utilization review as well.

Health plans will not need to maintain existing provider enumeration
systems but it still will need to maintain enrollment systems and processes,
and will need to collect enrollment data, validate data, health plans will
always have a need for more data for their business operations then the NPI
will provide. And the effect on clearinghouses is similar.

The NPI rule is available on our HIPAA website, which iswww.cms.hhs.gov/hipaa/hipaa2,
it includes the final rule, frequently asked questions, and analysis of the
public comments, and an overview of the NPRM. We will also be providing
information via HIPAA roundtable audio conferences and partnering with
professional organizations.

Thanks. Any questions?

DR. COHN: Karen, thank you very much for the informative update. I think
there probably are a fair number of questions, I know Jeff has indicated that
he had a couple and I’ll follow on his footsteps.

MR. BLAIR: So we’re up to 60 percent compliance with the health claims
submissions, correct?

MS. TRUDEL: Right.

MR. BLAIR: Is that based on the volume or is that based on the number of
entities?

MS. TRUDEL: For Medicare purposes that’s based on a percentage of
electronic claims coming in in a compliant format.

MR. BLAIR: But is that individual claims —

MS. TRUDEL: It’s volume, volume of claims, not volume of submitters.

MR. BLAIR: Okay. Do we have any numbers of compliance for any of the other
HIPAA transactions besides claims submission?

MS. TRUDEL: Medicare is collecting information on claim, the remittance
advice, and the COB at this time, and I have to apologize, I neglected to
memorize the remittance advice and the COB numbers.

MR. BLAIR: No problem, next question. Congratulations again on having the
final rule out for the National Provider Identifier, and it’s less then 1,000
pages. And the question I have is one of the comments you made in describing
what was included and not included was that it wasn’t required to include the
educational background of the provider and what I’d like to know, since we’re
heading down a path where we’re going to be dealing with national standards for
e-prescriptions and more and more looking at electronic signatures, if the
National Provider Identifier provided some degree of certification, somebody is
who they say they are, then it might begin to offer some type of opportunity
for authentication. But from what you were saying I was starting to get the
feeling that it really isn’t a certification that someone is who they say they
are. Could you please help me understand whether it is or it isn’t and do we
need to supplement it or —

MS. TRUDEL: I think that there are several issues here, one is that it’s a
lot easier in some ways to assure who an individual is then who an
organizational provider is because then you get into the additional complexity
of not only is the person requesting the identifier who they say they are, do
they have the authority from that organization to ask for the identifier in the
first place. That was a level of complexity that we did not feel that we could
get into at this point.

So no, the NPI does not convey any sort of notion of yes, this person is
definitely who they say they are, whether it’s an individual or an
organization.

MR. BLAIR: Or more explicitly whether they’re board certified in surgery or
not?

MS. TRUDEL: Exactly, exactly.

MR. BLAIR: That is not there.

MS. TRUDEL: No. And again, that was consistent with what we thought the
scaled down approach should be.

MR. BLAIR: Okay, thanks.

DR. COHN: Karen, I guess I’ll ask some of my questions, which, and I will
apologize, I’ve not yet read through the final rule so I’m sure that probably
it’s in the final rule or in the FAQs. I was just sitting here listening to
what you were describing and clearly I think we all get that this is not a
credentialing number and indeed as we all know health plans, Medicare, everyone
does a much more exhaustive credentialing process but this is an important
piece of the whole thing. But having said that I found myself, I mean I’m both
happy to see that we’re not using location codes on top of things to identify
locations and I’m understanding in how you’re identifying organizations that I
think an organization has the flexibility to get identifiers for, I mean
literally almost any address that they deem is important just because of that
flexibility. But explain to me if you’re an individual provider and you have a
couple of different locations of practice, how exactly does that work? I didn’t
hear that you wind up with three NPIs, do you wind up with one NPI and then
three different address with that NPI?

MS. TRUDEL: That’s correct. One NPI, three addresses, and we’re only
collecting one of those three addresses, any which one that they want to
provide as the location of the practice in addition to a mailing address.

DR. COHN: And so you’re talking about the change request for addresses —

DR. ZUBELDIA: Can I help you with that?

DR. COHN: Oh, please, thank you.

DR. ZUBELDIA: The expert transactions have a secondary identifier called
the site code, so you have the primary identifier which would be the provider,
and the secondary identifier which would be the site. And the provider assigns
their own site codes, typically traditionally the industry has been using a
four position alphanumeric site code created and designated by the provider.
For instance a university may designate as a different site each one of the
departments, so when they get the remittance advice the site code comes back in
the remittance advice and they know how to post the payment. Same thing happens
with multi-location providers, physicians, that typically have been designated
their own site code.

DR. COHN: Well, but I was also hearing within the NPI that there’s actually
the capability to get separate identifiers so that locations can have different
NPIs for each site, so I guess there’s two ways of handling this. You can have
one code and then how many possibilities are there, how many different location
codes can you have if you’re a complex provider?

DR. ZUBELDIA: Four position alphanumeric —

MS. TRUDEL: 999.

DR. ZUBELDIA: No, no, it’s four to the power of 26, so it’s a big number.

DR. COHN: I’ll look up that number off line. Okay, that’s helpful, so it
sounds like there’s basically two approaches for organizations. Obviously I was
just trying to think of how an individual goes around billing, recognizing that
sometimes geographic location does have an impact on billing and payment and
all of that.

MS. TRUDEL: right, from our perspective, from the NPI, NPS’s perspective,
the individual gets the one identifier.

DR. COHN: Okay. Now the second question, and one thing I’m sure this is
another FAQ piece which as I said have not reviewed, I know earlier on there
had been some discussion that there would be some, at some point that currently
existing databases would be sort of transformed, and by that I mean not
necessarily completely transformed but for example physicians with UPINs, and
obviously that’s a relatively frequent number that many if not most physicians
have, that that database and those numbers would just, they would suddenly
receive NPIs. Is that going to happen or do people have to apply for new ones?

MS. TRUDEL: We’ve left that open at this time. We got a number of comments
in the proposed rule that that would be a really great idea because it would
simplify life for people who already have identifiers. We also got comments
saying if the data is not good you are just perpetuating bad data in a new
database. And so there’s still some assessment of the accuracy of data that we
have in terms of Medicare files before we’ll make a decision as to whether
we’re going to do that or not and to what extent.

DR. COHN: Well, okay. I guess the final question about that is is that just
as health plans have, I mean our commercial health plans have their own
credentialing process will this be an opportunity to, I mean you will obviously
still require the additional data within Medicare that’s resident in a UPIN,
and so that will continue to be a separate credentialing process and probably
this will be an occasion for you to sort of reflect the quality of your data
and databases is what it sounds like.

MS. TRUDEL: Right, for instance the Medicare Physician Enrollment form, the
855, will continue to be required and it will link up, the system that carries
that data will link up with the NPS, so that the identifier that’s issues is an
NPI.

DR. COHN: Well, okay, great. Other questions? Marjorie?

MS. GREENBERG: Congratulations as well. Maybe you said this and I just
didn’t catch it but if an organization allows its subparts to have NPIs will
there be something in the database that will indicate what organizations those
subparts are associated with?

MS. TRUDEL: I believe so, I’m not absolutely positive, I’m pretty sure that
there’s a hierarchy but I’ll have to check.

DR. COHN: Kepa?

DR. ZUBELDIA: Karen, congratulations for getting this out, it’s great news.
You know how when you send an email sometimes you get that feeling, oops I
forgot something right after you press the send key? I think there was a
typesetting error in the list of the database elements, somebody forgot to put
in the provider’s city, the provider address is required, and the state and
zip, but the city was missing. So you may want to relay that to Pat Peyton,
they may have to correct that.

MS. TRUDEL: Thank you.

DR. ZUBELDIA: I have a couple of questions on the taxonomy code, it’s a
required element, are the taxonomy codes going to be reflecting taxonomies for
institutional providers or for non-person providers, entity providers? Because
right now the taxonomy codes don’t get into a lot of granularity there. I mean
they have to —

DR. ZUBELDIA: And then you mentioned the three levels of data dissemination
and in the NPRM there was an indication in the database as to what level
dissemination each level corresponded to. In the final rule there is not that
indication. Is that something that was part of some other rule or somewhere
else or can we use the same level of dissemination that was in the NPRM?

MS. TRUDEL: That will be part of the data dissemination strategy that I
said would be forthcoming. Basically we’re looking at the data that we have
now, we will be storing in the database, looking at the privacy act and other
constraints and trying to figure out what can be in public use files, what can
be in files if someone signs a data use agreement with us, and essentially
crafting a strategy based on the data that we have and the rules and
regulations that are already in place.

DR. COHN: Anything else? No? Other questions? Michael.

DR. FITZMAURICE: Again, congratulations on the large volume of claims
coming in electronically. But let me ask, is that 60 percent of the claims
coming in from Medicare providers, are they completely HIPAA compliant? Are
they sufficient for Medicare payment?

MS. TRUDEL: They’re completely HIPAA compliant.

DR. FITZMAURICE: Wow, that is impressive. Secondly, in one of your slides
NPIs effect on providers, you note that COB payments will come sooner. Is that
they may come sooner, is there anything in the law that says that they actually
will come sooner or is it just logical that if it’s more efficient people
wouldn’t want to hold on to the money, they’d want to pay it out faster?

MS. TRUDEL: There’s no requirement on the timing for COB payments but it
does kind of stand to reason that if everybody identifies the provider the same
way it’s going to make it a lot easier to link up files and communicate and do
all the things necessary for payment of a COB claim.

DR. FITZMAURICE: I agree, it does stand to reason.

MS. TRUDEL: We probably shouldn’t have been quite so bold about that
statement, though, point well taken.

DR. FITZMAURICE: Third, what should the covered entities be doing at this
time? One of the things probably is that they should be preparing for a
national health plan identifiers since that’s coming down the road and it’s one
of the HIPAA requirements, and I guess one of the first questions they should
say is how many digits should we prepare for. If they prepared for a ten digit
national health provider identifier code do you expect that to be sufficient?
Because if they’re going in for a provider identifier, if they’re going in for
a health plan identifier, can they make both of them ten digits and save the
programming time at this point? I realize it’s not official because it’s not
out as a —

MS. TRUDEL: I can’t even comment on it.

DR. MCDONALD: Sorry, I didn’t hear the whole presentation, but would you
expect providers to have only, I mean physicians or practitioners, to have only
one identifier?

MS. TRUDEL: Yes.

DR. MCDONALD: And what will outsiders be able to get of this database? I’m
asking more specifically, we’re trying to connect a lot of hospitals in our
city, could we get the database under some arrangement?

MS. TRUDEL: Again, that leads back to the dissemination strategy that I
mentioned to Kepa, we’re still working on, so the levels, aside from the
enumerator and HHS are what can we release to the general community under the
privacy act and what data can we release that contains privacy act data but
that could be released under a data user agreement.

DR. COHN: Public questions? Dan, do you want to come up and introduce
yourself and ask your question?

MR. ROUDY: Dan Roudy, American Health Information Management Association,
just a couple operations questions, Karen. We have a gap of one year between
large and small providers, so that means, health plans, so that would mean that
providers would have to continue to carry multiple numbers until we get through
the second phase of the implementation and is there any way that they’ll be
able to identify which payers are considered large versus small?

MS. TRUDEL: The definition of a small health plan is in the transaction and
code set regulation and again, this is an issue that’s going to come up with
every single HIPAA standard and actually would have been an issue with the
transactions and code sets had we not had the year extension. So there is that
one year where there’s potential confusion and I think we have plenty of time
for plans to state their expectations about what they think they are. For the
most part Blue Cross/Blue Shield plans, etc., they’re not small, it’s the small
ARISA(?) plans, the funded ARISA plans that are likely to be that.

MR. ROUDY: The department wouldn’t have a problem however if a small plan
came forward and got involved in the system early.

DR. FITZMAURICE: — on a contingency basis, do you anticipate that 12
months from today that no contingency acceptances will be accepted? That all of
them must be fully HIPAA compliant? Is 12 months a long enough time period as a
rough guess, not as a firm statement?

MS. TRUDEL: Well, first of all I can’t speak for the industry as a whole
because we’re talking about plans that are in a variety of places in terms of
percentage of compliance that they’re working with. And as I think I said
before Medicare is continuing to monitor our progress and at a point in time
where we feel that we’ve got a high enough percentage of compliance we’ll then
begin to make plans to take down the contingency and to do outreach to our
provider community. We aren’t in that place yet and I can’t even tell you when
we are going to be in that place.

DR. COHN: Other questions? Clem and then John Paul.

DR. MCDONALD: Given the optional fields how would you be able to avoid
having duplicates? I mean I can imagine someone practicing two sites and the
practice manager is submitting these forms and a Social Security Number is not
required, birth date is probably not enough, disambiguate —

MS. TRUDEL: First of all birth date, gender, state license, number —

DR. MCDONALD: Is that required?

MS. TRUDEL: It’s optional, it’s required for some provider types, so I
would say for physicians it’s going to be required. And when we did, we did do
de-duplication exercises a number of years ago on our own data, we found that
the state license number was the one where we caught the most dupes because the
names were slightly different, you’re right, the birth date alone is not enough
but state license number is an enormous help.

DR. COHN: John Paul?

MR. HOUSTON: This may be a stupid question but is there any allowance, I
know the NPI is national, for dealing with cross border like Canadian and out
of country providers who might be billing insurance in the United States? Was
that intended with this?

MS. TRUDEL: That’s a really good question. I don’t think that entities that
are outside the U.S. would be considered a covered entity under HIPAA but I
would have to check with the lawyers.

MR. HOUSTON: Well, I don’t think they’d be covered necessarily under HIPAA
but it would be interesting, if we’re trying to set up a national identifier
for simplicity I was just wondering whether you had a Canadian physician, or
physician office, who would be billing a U.S. insurer, whether they would be
able to get an identifier in order to streamline the insurers’ operation.

MS. TRUDEL: I’m sure if my NPI expert were here she could answer you but I
will at least take the issue back and make sure that we thought it through.

DR. ZUBELDIA: Looking at the rule, the mailing address has a field called
country code. I don’t know if that will be allowed or not but there’s a place
here to say —

MS. TRUDEL: I defer to the alternate expert.

DR. ZUBELDIA: — send my mailings to Canada.

MR. HOUSTON: Kepa can be after tomorrow, right, officially after today.

DR. COHN: Any final questions for Karen? Well, Karen thank you both for
updating us on where we are with implementation of codes and code sets and
financial transactions as well as this very exciting new rule that’s come out.
I think they’ll be lots more questions and I suspect you’ll be updating the
full committee tomorrow on some of this stuff. Am I correct on that?

MS. TRUDEL: Right.

DR. COHN: But I think you have obviously, I want to congratulate you, I
mean I think it’s very good work, we’ve obviously been waiting I think a long
for these and it’s nice to see them step by step coming out. So obviously I
think it’s good for the industry now to know exactly what the format and
information required so it can move forward to begin to do the implementation,
so thank you.

DR. COHN: The next item, and this is really more of a short discussion then
a long discussion, on the agenda it says draft letter to the Secretary
concerning claims attachments. I think you’ll all notice that there’s not a
draft letter in front of you for consideration. I think after much wordsmithing
and attempts to get a letter right I think we’ve, or at least I’ve come to the
conclusion and I want to just discuss it with everybody to make sure we’re on
the same page, I think there’s a sense that we need to do some additional
hearings and further investigation into the world of claims attachments.

We heard obviously from some of the providers and from some of the
standards organizations in December, I think from my view I think one of the
most important things or ideas that came out of that session was the idea of
demonstration projects to help I think encourage, refine whatever standard is
brought forward with an NPRM or otherwise. But I think that there’s also a need
for us to sort of listen a little more widely to the industry to hear about
alternative approaches that appear to be being implemented around claims
attachments just to get a sense of that. And obviously we’re also beginning to
receive letters and questions regarding actually concepts of both
administrative simplification, exactly how claims attachments relate to privacy
concerns and others, that probably we should take a little time to hear before
we come forward with a letter.

Now I’m making all of these statements, I’m sort of curious about thoughts
from the subcommittee if this is indeed more then just my own sense of the
matter. I think my hope would be is that in March we may be able to find some
time knowing that we obviously already have a whole lot of things on our
agenda. But the idea might be to spend a little time hearing more from the
industry on these topics and sort of getting a better sense of how all this
should go forward.

Thoughts, comments? Stan?

DR. HUFF: I think that’s a prudent course, I mean I haven’t seen any of the
questions that don’t necessarily have answers but I think they certainly
deserve careful consideration. So I think it would be prudent to have some more
hearings and talk about it and make sure that all of the issues are known and
understood.

DR. COHN: Thoughts or comments? Kepa?

DR. ZUBELDIA: I won’t be here in March.

DR. COHN: You might be, you might be testifying, Kepa. Other comments on
this? I think certainly, Jeff, did you have a comment?

MR. BLAIR: I just wanted to share, actually in the cab from the hotel to
the meeting this morning you and I talked about this a little bit and for the
benefit of the rest of the subcommittee I just wanted to share the feeling that
I had about this because it’s kind of mixed. On the one hand I feel like we
don’t want any delay going forward with an NPRM. Does that mean we need to
write a letter to support that? And I think that’s a matter where I feel that
we should leave that to the chair totally to determine whether a letter is
needed to support an NPRM. The other thoughts that I had were that I do think
that the testimony that Wes Rischel gave us was outstanding and that it’s going
down the right path, but it’s so early and the demonstration projects have not
occurred yet, and apparently there’s other entities and organizations, by the
way, do we all have copies of the letters we’ve received from the other folks
that are beginning to raise questions? Okay. And they’re raising valid issues
and questions. So Stan, I would just agree with your word, is that it just
would be prudent for us to take the additional time to listen before we
actually write a recommendation letter.

DR. COHN: I guess the other piece and the one thing that I think will say
in public session, unfortunately it isn’t in the letter, or any letter, but we
may want to actually expedite this aspect depending on what we conclude after
hearing a little more, is that I think it’s absolutely critical almost no
matter what happens that there needs to be demonstration projects. And I think
that that to me is the one item, now I don’t necessarily think a demonstration
project has to occur or be completed before an NPRM is produced but I think our
thought is that it is something that would be very useful in the process of
coming to a final rule to sort of help refine it, give us real life experience
with a standard for claims attachment. And certainly I think we need to do
whatever we can to help encourage the Secretary to move forward with whatever
help he can provide in terms of enabling demonstration projects on this. I
think we all think there’s an important business case that if done right this
would help enable, but I think that’s something we need to get out in the field
and test.

Anyway, other comments on this one? It sounds to me like everybody is sort
of comfortable with the current status of all of this and we will just reflect
it towards the end of the day on how we put all this together with everything
else that we have to do, and I think I’ve heard at least from some of you, I
reflected yesterday about whether we just start having four day, excuse me,
three day sessions of the subcommittee on hearings versus more hearings for the
remainder of the year and I’ve at least heard some comments that a number of
you think that more frequent two day hearings may be the way to go. But as we
put more on our plate for the year obviously it does sort of beg the question
of how we on a timely basis address all of these things. And not just in a
timely basis but in a way that is up to our standards for having been thorough
and authoritative in our judgments on these things. So, anyway, yet another to
do for the year.

DR. ZUBELDIA: How are you going to promote the demonstration projects
without the letter? Somehow I’m concerned that by not sending the letter the
demonstration projects may be set back waiting for something else to happen.
And I think the demonstration project needs to move on.

DR. COHN: Well, without making a comment there, other thoughts?

DR. MCDONALD: I would be concerned the same way because all the way along
we know that everything gets delayed until there’s some sort of trigger in any
of these things and I don’t know that we’ve had demonstration projects for most
of the things that we proposed. I think it’s a good idea, I think we should,
but I think the same thing, unless it looks like there’s some really action
going on people are busy enough that they stay busy with the other things.

DR. COHN: I agree with you and that was sort of the quandary that I was
having. I think we’re going to have to mull over this one a little bit, I mean
certainly one obvious solution to this one, or at least a way to expedite a
letter as well as hear more from the industry, would be to have a session soon,
in March, to consider this and basically put it on a fast track consideration,
hearing more from the industry and then coming out with a letter. And
recognizing that there’s another full meeting of the full committee as early as
early March, I mean the reason I’m hesitating on this one is because it moves
us back into a three day session of the full committee, I mean with us having a
day and then two days of the full committee in early March. If we wait until
late March we’re coming up with a letter for June, which does seem a long time
from now. So I’ve been, based on what I was hearing I’ve been a little
reluctant to start suggesting to the subcommittee that we do a hearing for a
half day or whatever in early March. But let’s reflect on that as we talk about
other items, such as e-prescribing, and look at the overall work plan for the
year.

Steve, did you have a comment?

DR. STEINDEL: Just a comment on meeting schedule. Many of us might be here
on February 18th with the NHII, and if we tack a day on that.

MS. GREENBERG: I think Privacy and Confidentiality is meeting the
18th and 19th.

DR. STEINDEL: And NHII is the 18th.

MS. GREENBERG: And NHII is meeting the 18th.

DR. STEINDEL: And there’s a good overlap between this subcommittee and the
NHII Workgroup.

DR. COHN: I think that that’s a thought, I mean obviously that’s a little
fast for putting together a hearing, which I think is the —

DR. STEINDEL: But I think that there’s a lot of interest.

DR. COHN: Yeah, I think there is a lot of interest. We’ll take it offline
for the moment, I think we’ll reflect on it as the day goes on. I’m just, as I
said, like Kepa, like everyone else, it’s sort of, the part that I’m concerned
about is obviously getting demonstration projects to begin to show proof of
concept, to begin to show that it really gives us the value and administrative
simplification that we’re seeking. But I think we do need to hear a little more
from the industry in all of this. So probably by the end of today we will
hopefully be making some plans, obviously this is also complicated by the fact
that we are doing a transition on committee members and all of this.

DR. ZUBELDIA: My preference would be to send the letter perhaps changing in
the letter, removing whatever you want to remove as far as recommendations but
strongly recommending that there be demonstration projects. And then perhaps
send another letter after the February 18, 19 meeting. The demonstration
project needs to be kicked in gear an they’re not going to do anything until
they see the NCVHS saying yes, this is the direction we’re going to go, they’re
just going to wait.

DR. COHN: Well, I don’t know, I think that’s an open question but certainly
I think we might be able to help move them forward. Marjorie?

MS. GREENBERG: And certainly if you want to focus some attention on this
having two letters several months apart is not a bad thing.

DR. COHN: Okay, well let us, I don’t think I have an answer here but I
think we’ll reflect on it as we go along, and obviously we have a number of
options and as I said certainly there’s a need for a session to talk more with
the industry about all of this. I think what would be best is if we could talk
to the industry and then hopefully come out with a letter that isn’t, as
commented, the complete evaluation of claims attachments but at least moves us
to the next stage of demonstrations assuming that we come to that conclusion
after a little more from the industry. But let’s see if we can make all that
happen in a, what I think I’m hearing is a timely fashion, and I think we are
in some ways helped by the fact that for a variety of reasons we have NCVHS
meetings occurring at really sort of a torrid pace over the next six weeks, so
I mean there should be some way for us to leverage that. And I think that’s
what I’m sort of hearing is it’s fine to not have a letter today but let’s move
forward with this in an expeditious fashion.

Okay. Now with that I think it’s time for our break, we will take a 15
minute break and come back at 11:10.

[Brief break.]

DR. COHN: Will everyone pleased be seated, we’re going to get started with
our next session. Would everyone please be seated we’re going to get started
with our next session.

Agenda Item: Dental Standards Issues – Dr. Cohn

DR. COHN: Okay. Well, I want to welcome our distinguished guests for a
discussion of what’s been described as dental standards issues. I obviously
want to thank you for coming and joining us today. I’m going to ask each of you
to introduce yourselves and your positions, and then obviously we’ll start with
Dr. Albert —

DR. GUAY: Guay.

DR. COHN: I’m sorry, that’s what I thought it was but the u —

DR. GUAY: It’s spelled correctly, that’s very good, a good start.

DR. COHN: Okay, well that’s a good start. Anyway, would you like to start
by just introducing yourselves?

DR. ADAMS: And they didn’t spell my name right, I have to say that, I’m not
a Rodger, I am a Roger, Roger Adams, and I’m the immediate past chairman of the
board of the National Association of Dental Plans and a current foundation
board chair.

DR. SCHOOLEY: I’m Dr. Ed Schooley, I’m the vice president dental director
for the Delta Dental Plan of Iowa, but I also play a role with the National
Policy Committee for Delta Dental Plans and represent all the Delta Dental
Plans on the Coder Vision Committee.

DR. GUAY: Thank you. Well, Dr. Cohn, subcommittee members, good morning and
I already introduced myself, I haven’t been authorized to do this but on behalf
of the senior citizens on this morning’s panel I think you for having the
testimony late enough so we could wake up and early enough so we don’t nod off
in the middle of the testimony.

On behalf of the American Dental Association I really want to thank the
committee for their interest in dental standards and I have to say and for your
patience in the past year or so in this process. I was interested in hearing
what Dr. Cohn said about why we’re here today because I just wrote a couple
scribbled notes about that. What’s our main business here today? And we think,
and he agrees and the subcommittee agrees I hope, is talking about a diagnostic
code terminology for the individual patient health record, the PMRI standards.
And if we think about a diagnostic coding system it’s almost intuitively known
that it has to include all the possible diagnoses a dentist may encounter
during interaction with patients. I don’t think that’s a hard concept to
understand. So we have to have a diagnostic coding system that allows dentists
to put in their patient record all diagnoses that they discover or that they
deduce from their interaction with the patient, not just those codes that are
related to insurance claims processing, unless you have a code that says
something like diagnosis not recorded because not relevant to claims
processing, I think that’s a little bit short of the standard for a good health
care records, although it certainly would be more simple.

We’ve heard criticisms of the SNODENT system that it’s too complicated and
there are too many codes, and that’s hard for us to understand when we have to
cover all diagnoses, you need a code for each of the diagnoses. We’re also
interested, see I read the testimony that Delta has submitted to you about
their new interest in diagnostic codes and claims adjudication adding to them
the claims process, it’s interesting to us because there have been diagnostic
coding systems with dental items for 30 years and they’ve never been utilized
in the claims adjudication process. Up until this date there’s been no interest
in diagnostic codes and we certainly are interested in that. And we’re also
aware that there’s going to be some opportunities to use modifiers to do
diagnoses, a number so small that it’s certainly, the event is a name for a
diagnostic coding system wouldn’t accrue to the small number of codes that
they’re talking about.

SNODENT, you know about it, we’ve been talking about it for a while, it’s
not available to anybody, the Library of Medicine on their website, you have to
have an agreement with the Library of Medicine. We sent a copy to Delta to look
at and they returned it without looking at it, so kind of a confusing system.

So basically today I have two items of business. One is I’d like to provide
you with an update on SNODENT and try to answer some of the content questions
that you’ve posed to us about SNODENT in your consideration for it being
recommended to the Secretary as a standard. And then as a separate item we’ll
try and describe some of the other questions that have been posed to you, or to
us, about our dental procedure codes, a totally different system. I think it’s
important to separate those two things so I’m going to in my discussion talk
about the diagnostic coding system, electronic patient health record, and then
we’ll answer questions about the procedure code system related to claims
adjudication, the two different things we’re going to be talking about.

We certainly appreciate the opportunity to talk to you about SNODENT again,
we’ve had several discussions, and we understand you’re looking for additional
information about the relationship between SNODENT and SNOMED CT, the medical
system, coding system that you have proposed to go forward to the Secretary
already. Well, just to briefly review historically, in ’98 the ADA was desirous
of formulating a system for diagnostic coding terminology taxonomy and we
wanted a system that would serve the needs of the profession and after looking
around at existing coding systems we thought about starting new, we determined
that the architecture and the form and the structure of the SNOMED coding
system owned by the College of American Pathologists fit our needs perfectly
and fit the needs of the profession perfectly as opposed to those that we had
already seen. And so we made an agreement with them to develop SNODENT using
the architecture, hierarchical architecture of SNOMED, and with their
cooperation we developed SNODENT and they assigned SNOMED codes and it’s now
totally integrated into the SNOMED system. So if you look at the SNOMED system,
which you’ve already looked at in great detail, in that system is SNODENT. Not
identified specifically as SNODENT but intermixed in the terminology, the
different systems, are the codes that make up SNODENT when they’re abstracted.
So SNODENT is sort of a subset of the SNOMED coding system, maintained by the
ADA with the cooperation of the editorial board of SNOMED.

SNOMED has taken some changes over those years, the version 3.5 has
transformed into the current SNOMED CT structure, primarily by addition of some
codes that the British had been using, coding V3(?) in the British coding
system has been integrated into SNOMED and that has some dental terms into it
also, and so that has now evolved to the current SNOMED configuration of SNOMED
CT. ADA maintains a relationship with the editorial board of SNOMED.

For the maintenance process, which you had some question about for SNODENT,
is very similar to that for SNOMED. We have an advisory committee on dental
electronic nomenclature indexing and classification and we affectionately call
it the Code NIC. And this committee is the primary source of input and
recommendation to our Council activity concerning SNODENT. And this committee
is made up of representatives from all the recognized dental specialties, and
representatives from the American Dental Association and those councils that
are concerned with the dental commerce so to speak.

The ADA is working now on a system to include payer representation on that
so that’s our, clinical structure requires we go through a system that’s
already been started and that should be completed in April of this year and
it’s my guess that there will be then an invitation to certain payer
organizations to become members of the Code NIC and have a voting voice in that
committee.

I kind of looked first at this when I was thinking about this, about here’s
a system that no payer, dental payer uses at all in their claims adjudication
process, and here’s a system that we’ve developed and we have a maintenance
process for that, and the payer reps want to be a part of that system, and it’s
sort of, I live in Chicago, and it’s sort of like me asking to vote in Indiana
because some day I might move there, so it was a kind of a novelty situation
but the ADA has accommodated that and we will be recommending that there be
payer membership and input into that committee.

Our executive direction and I here at the last meeting promised an open
process for maintenance to the SNODENT coding system, and we’ll do that. The
Code NIC committee takes testimony from any interested party, including
testimony through the internet through our website, so anyone who has an
interest in the diagnostic coding system can put input into this committee,
changes and modifications, whatever, and we’ll continue that. The Coding
Committee then passes judgment on these recommendations, much like you to do
move up forward to the Secretary, this will move up to our council which will
then determine which recommendations are chosen, what changes will be made,
those recommendations then will go to the SNOMED International Editorial Panel
for their consideration for including into the SNOMED.

The ADA developed SNOMED and we’re proposing as a standard that it become
an integral component of the electronic health record for dentistry, for dental
patients. And we think that the adoption of an electronic health record depends
really on the codified system that’s accepted by practitioners, so we urge, and
this sort of was developed by practitioners, we urge that your committee
designate SNODENT as a core terminology for dentistry, the patient medical
record, for reasons we’ve already enumerated and we would encourage its use by
the profession. For those reasons in summary SNODENT’s a complete system, it’s
contemporary, it’s not filled with archaic non-used terms as some codes are.
Its hierarchical architecture is ideal as we’ve seen and I think you probably
agree with that, and it’s ease of expansion in a logical manner is really easy
to do.

We’re grateful for your consideration and we look forward to your further
consideration of SNODENT and recommend it move forward to the Secretary. Let’s
close that book, the discussion of SNODENT in my presentation is finished.

We’ll move on to the other issues that have come forward that have come to
the surface. Unlike diagnostic codes, which have never been a part of dental
transactions the ADA procedure code is a long standing mechanism for dentistry
for the dental treatment that they provided to patients to payers. It’s make in
the system is accomplishment by a legally binding court approved settlement
agreement between the American Dental Association and the Delta Dental Plans
Association of America, and this agreement clearly spells out exactly how
changes in the code can be made. The ADA modified its code and maintenance
procedure to accommodate this agreement and has rigorously abided by those
terms since the terms were decided upon or agreed upon.

The settlement requires that a code revision committee be established,
which is an entity with representation of both dentists and third payers, third
party payers, and a national purchaser of dental benefits to consider changes
to the code. Any changes to this mechanism had to be agreed upon by all the
signatories to that agreement. As the nature of the dental benefits industry
has changed, much like the medical/surgical/ hospital industry has changed over
the year, new market forces have emerged. A relatively new organization has
emerged that represents a substantial portion of the dental benefits industry,
the NADP, and you’ll hear from their representative shortly. Recognizing this
change to dental benefits environment the ADA has recommended that the code
revision committee, dental strategic code revision committee, be expanded to
include a representative from NADP, and another representative from the ADA to
maintain its balanced representation as determined by the settling agreement.
To this date the proposal has not been accepted by our partners to the
settlement agreement, DDPA, we’re hoping we can agree on this change relatively
quickly.

Recently some players have recommended that several modifiers be added to
the procedure code and that are in fact diagnoses. This expansion of the
procedure code into the area of diagnosis by the inclusion of a relatively
limited number of diagnosis in the form of procedure modifiers was considered
by a special ad hoc committee workgroup of the code division committee. They
recommend that the CDC defer action on this request in light of the emergence
of SNODENT and the committee will monitor further development in this area.

There’s been some discussion about modifiers to procedures and I think our
language is pretty clear that a modifier to a procedure should be talking about
things that modify the procedure, not their diagnosis that results in the need
to the procedure. So it’s sort of a jumbling of things by putting diagnoses
into procedure codes, there’s a mechanism for keeping them separate and clear
and clean and we think that should be abided by.

We think that putting diagnostic information in procedure codes, to replace
local codes and specific needs in individual dental benefit plans, it would not
result in a net administrative saving, and would probably thwart the HIPAA goal
of standardization and transactions and code set regulations. And we think this
would delay or maybe even prevent a great number of dentists migrating from
paper claims to electronic claims.

Let me conclude the discussion of the procedure code by expressing our
appreciation to this subcommittee for its interest in learning how the ADA is
working to bring the various dental communities together, involving and
resolving dental transaction concerns. We really believe that those involved in
dental transactions on a day to day basis are best equipped to resolve problems
as they present themselves at that level of day to day business.

Finally, addressing the main business at hand, that is the dental
diagnostic taxonomy for electronic health record, thanks again to the
subcommittee for the time and effort you’ve spent in considering SNODENT as a
core dental terminology and express again our desire that the ADA, that you
recommend SNODENT as a core terminology and make the recommendation to the
Secretary.

And I’d be happy to answer any questions or expand upon anything I’ve
talked about. Thanks.

DR. COHN: Dr. Guay, thanks, and we’ll take questions and discussion after
everyone’s had a chance to testify.

Agenda Item: Dental Standards Issues – Dr. Adams

DR. ADAMS: I don’t know who arranged the seats but I feel like the last
couple of years where I’ve been actively involved in trying to resolve between
the settlement agreement of DDPA and ADA, I think whoever did this did this on
purpose because, in fact I was talking with Al about this, I’ve been talking
with the senior leadership of the ADA almost on a daily basis to hopefully come
in today and share with you a resolution and so I think they’ll rename me the
negotiator rather then the chairman of the board.

I’m delighted to be here on behalf of NADP, or the National Association of
Dental Plans. I’m going to review with the subcommittee briefly kind of an
update of where we are in the improved communications between NADP, the ADA,
and Delta Dental Plans Association, particularly addressing the Code Revision
Committee and our statement from the last testimony of this committee, some
brief comments on the licensing of CDT codes, and then I will make some
comments on SNODENT relative to NADP.

Most of my comments in the verbal part of this testimony is going to be a
high level review of what was in the written, I’m not going to go through that
in detail, you have that to reference. I really find myself in an interesting
position here because I have blood that flows through me from all three
associations. I graduated from dental school in 1974 but I completed three
different specialty programs in dentistry. I’m an oral and maxillofacial
surgeon by training, I’ve completed a residency in oral pathology, I’ve been
featured on the cover of the Journal of the American Dental Association, I’ve
been on the Medicaid Advisory Panel for the American Association of Oral and
Maxillofacial Surgeons, been an active member of the Utah Dental Association on
their board of Directors.

I’ve been a participating dentist with Delta Dental Plans for 23 years and
right now am very active with the Delta Dental Plans Association on other
initiatives that are very exciting, and so I’ve worked very closely with them
and obviously I’ve been on what many of my colleagues call the dark side, for
the last eight years, with the National Association of Dental Plans.

And I get asked frequently why do I belong to the National Association of
Dental Plans or why do I belong to the ADA or DDPA. I’ll tell you the whole
reason I belong to these three association is the whole reason I went through
and got three different specialty degrees, and that is ultimately what we’re
all here about with the HIPAA and everything else is bottom line we want to
improve the health of the people we serve. Simplification is to get us to that
point. Unfortunately we all get so relegated to our little silos that we
sometimes forget the overall purpose of what we’re trying to achieve and that
is ultimately providing a benefit that will improve the health of our patients.
To that end I certainly hope my testimony today will have some effect.

Just briefly, NADP, and did we hand out that, you all have this little pie
graph and this is updated as of just really the data here is fairly accurate.
And this is just a pie graph that kind of demonstrates what Al introduced. The
National Association of Dental Plans is a new association, but it represents
now a significant block of the dental benefit companies. We have dental HMO,
PPO, indemnity discounts plans. Our members include major carriers as well as
regional and state, single state companies. We provide more then 70 percent of
all networked based dental benefits and one third of the indemnity benefits in
the United States. As you can see this adds up to about 56 percent of
unduplicated market share as compared to the other trade association members.
If you boil all of this down National Association of Dental Plan members
provide benefits to approximately 95 million of the 155 million Americans that
have dental benefits.

So we appreciate that the American Dental Association and certainly Delta
Dental Association, many of their plans are members of our association, that
the ADA has recognized us as a legitimate representative within the dental
benefits industry. In fact to our knowledge, and we’re fairly accurate with
this, there’s no other trade association, health or dental, that can claim this
breadth of representation in the dental benefits industry.

Now in February of 2002 we appeared before this committee and voiced our
support of the electronic transactions and our commitment to compliance with
HIPAA. We also voiced our concerns with the HIPAA dental code set development
and maintenance primarily surrounding the exclusion of NADP on the CRC and
licensing requirement, including the CDT usage fees being imposed on the dental
benefits plans. Our objectives at this initial testimony before this committee
was to ensure an open process of maintenance of these standardized code sets,
and equitable representation of all parties directly impacted by the dental
code sets to govern and process as mandated by HIPAA, and a fair licensing of
the CDT code sets.

And as Al introduced we are just delighted to be here today and state the
process and the influence of this subcommittee has worked in this particular
arena. And I would like to acknowledge our appreciation and leadership to the
American Dental Association for facilitating a tremendous improvement. Not only
has the ADA been responsive to our requests for meetings, notices, and agendas
but they have been instrumental in facilitating changes that have dramatically
improved our access to code revision and maintenance process. Our written
testimony that you have documents several examples. The ADA has also recognized
NADP’s thorough, we have a complete process of code evaluation through our what
is called CDT technical advisory committee. This is a committee made up
primarily of dentists that are members of our, that are plan members, and they
all have clinical experience, and this committee works in an open and
predictable procedural mechanism by which they can comment on code set
development and maintenance. The ADA saw this at the last round of the CRC and
acknowledged the thoroughness that we did, in fact Frank was here and
acknowledged that.

NADP also appreciates and would like to acknowledge the ADA and Delta
Dental Plan Association for their effort this past year to expand their
authority so everything stays in balance. DDPA has recommended that the seat,
and they support the initiative to have NADP at the CRC table, so both
associations are in agreement but because of the settlement agreement are held
hostage by that settlement agreement. They both agree, DDPA has made a
recommendation, and we have that referenced in your testimony that NADP replace
the purchaser representative on the CRC.

Our position remains the same, and namely that all payer groups with
unduplicated representation in the dental benefits industry should have a seat
at the table. We feel this supports the intent of HIPAA and meets the higher
standard, and that is taking away all the silos and all the profiling and all
the turf wars, it serves our people better and it will help facilitate
improving the health of our members if we all can come to an agreement. And
we’re delighted, I think we’re just literally days away from having this
agreement finalized, so I’m going to put an end to that chapter in our
testimony, we’re just delighted that both the ADA and DDPA are working
aggressively to resolve that.

I would like to address very briefly, because we brought this up in our
last testimony, the licensing of CDT code sets. As we testified previously we
agree that the ADA has a legal right to license its copyrighted material. Our
written testimony outlines to the committee the difficulties that we have in
understanding exactly how the licensing fees would be applied, particularly
when we look at it from our larger regional and national member companies. I
again am very pleased to state that we are in active communications with the
ADA and very confident that a plausible and equitable resolution to the
licensing fees will be achieved. So I’m going to put an end to that chapter as
well. I will reserve the right if we can’t resolve this, I don’t see any reason
we can’t, but we have it on record that these matters are still open.

Now I’d like to go ahead and issue some comments if I could on the SNODENT.
And I’m going to refer here to this more to the written testimony, I’m going to
quote a portion out of that. But we’ve communicated to this committee this last
year via written letter our concerns with a privately developed unreleased
system of dental diagnostic codes. While the ICD-9 is indeed limited with
regard to dental diagnostic codes SNODENT is totally unknown except for the
fact that it includes what we hear, we’ve not seen it yet, some 6,000 codes.
While I agree, and I can’t agree anymore, if you’re an oral and maxillofacial
surgeon you need to understand all of the ICD-9, all the CDT, and you need to
be able to integrate them. So I do understand and certain understand the
complexities of diagnosis. That’s not the issue.

We’re the largest representative dental payer community, we believe that if
SNODENT is designated as a national code set under HIPAA the maintenance of
SNODENT must be accomplished in an open process established by HIPAA, and Al
has stated that will be done. But since the development of the process was not
open to payer participation and there have been no payer evaluation of this
system, significant time must be allowed for evaluation before any
implementation can reasonably occur. So we’re not arguing the fact that it
shouldn’t go in, we believe that it should. But there’s been no participation
by a community that represents a significant constituency and believe me, when
this hits the table from the third party payers it’s going to be a significant
cost to reprogram our systems to processing. We know that it needs to be done
but we have to have significant time and participation because I’ve definitely
seen from the clinical end, now understanding the third party payer end, when
you can get the communication together all of a sudden things make a lot more
sense and changes can occur.

So we just, we support, we agree, we want to be involved before it rolls up
to the next level. That’s what our recommendation is to be.

I’d like to just conclude and just state on behalf of the entire NADP
membership and all of the 95 million members that are insured under our plans,
I want to express our appreciation to this subcommittee and share with you,
that I’ve had the opportunity to share with you. We’ve had tremendous progress,
the communication barriers have dropped and we are resolving some critical
issues. And if it hadn’t been for your oversight I firmly believe this would
not have occurred this last year. And it’s the willingness I feel of three
excellent associations, Delta Dental Plans Association, the American Dental
Association, and the National Association of Dental Plans are excellent,
excellent association and it’s been my great privilege to be part of this
meaningful dialogue.

Thank you.

DR. COHN: Thank you. Ed?

Agenda Item: Dental Standards Issues – Dr. Schooley

DR. SCHOOLEY: Thank you and I would say the main point to perhaps take away
from my testimony today is kind of rooted in the current EDI rate for dental
claims, which kind of hovers in that 30, 35 percent range and kind of has been
there for quite some time now, whereas you kind of look on the medical side
we’re up in the 60 to 70 range. So in partial answer to one of Dr. Guay’s
questions, really DDPA’s renewed interest in diagnostic or modifier or some
kind of a clinical reason code is to really kind of facilitate the improvement
of dental EDI rate. Because we feel in many respects this is really kind of
part of the solution to increasing that rate. And I think also it’s borne of
the fact that there’s been, due to the fact that increased dental coverage and
many, many more Americans are now covered with some form of dental coverage.

My testimony today will basically be broken into two parts, and one is just
to provide you with an update on CRC matters from the previous testimony. And
the second part really is to address some SNODENT matters. I’m going to kind of
try to follow pretty much the written testimony here just so you can kind of
follow closely.

First an update on the continued improvements to the process, and I would
like to follow up on our past testimony and correspondence to update the
committee on the status of dental code set revision and the maintenance
process. If you recall it was at the last February 6th meeting and
requested, we requested the subcommittee’s guidance on the development of an
open code set revision and maintenance process. Subsequent to that hearing the
dental payer groups reached an agreement on very key areas of reform. As a
result of the subcommittee’s attention to the matter the ADA and the payer
groups did meet, developed changes to the CRC structure and overall process,
created a timeline, and put a lot of protocols in place. And as you know the
CRC is really the established mechanism for the review and revision of CDT,
current dental terminology procedure code set.

And in summary, these changes were adopted by unanimous vote by the CRC
then in August of 2002. I would note these changes probably would not have
occurred but for the interest of this subcommittee. We do see progress being
made towards achieving the overall goal of an open code revision and
maintenance process but we do feel there are some opportunities for improvement
as we go forward.

And briefly just a couple of follow-ups on some of those opportunities, the
first one having to do with the nature of ongoing changes to the CDT code set.
As we previously stated in the February 6th testimony in connection
with CDT we made the point that changes must be carefully designed to achieve
administrative simplification. When possible changes should be minimal and
objectively science based. At the upcoming February meeting of the CRC there’s
over, there’s roughly 186 new submissions for either new codes or code
revision, and again this is 186 to a code set that only currently encompasses
500 or less procedure codes. When you kind of look at those 186 code
submissions, really less then 10 percent purely kind of represent either new
science or technology.

In judging from past experience we expect 50 percent of these changes to be
adopted and often these changes represent forms of code splitting or unbundling
of procedures. We do believe billing code changes should not be designed to
necessarily enhance provider payment opportunities without increased services
to patients.

The other concern kind of has to do with the timing of changes. As you know
the current process does occur on a two year cycle but the point should be made
that frequent and pervasive changes to the code set, such as what are kind of
suggested with the 186 upcoming submissions, are rather disruptive and time
consuming to implement. Updates should be limited to make the process truly
more manageable. In the case of Delta Plans for most product what does this
involve, it means changes must be filed and approved by the state departments
of insurance, new benefit booklets, new fee schedules, update the websites,
reprogramming costs, and this should not be lightly looked at since Delta
Dental Plans collectively contract with three out of four dentists in the
entire country, that’s roughly 108,000 dentists. So all these expenses do add
up to the cost of dental benefit plan administration, in some cases serve only
to increase the cost of care, thereby making dental care, dental benefits less
affordable and really less available in the United States.

I’m going to kind of transition now to the discussion around diagnostic
code sets and SNODENT if you will. Dental payers often look to the medical
claims world for really models of improvement. Professional claims as you know
utilize two current procedure code sets, CPT and HCPCS. And this dual system
really serves as a checks and balances system for both providers and payer. The
AMA maintains the CPT code while collaboration of public and private payers
maintain the HCPCS codes. Dental claims, on the other hand, only utilize one
CDT dental procedure code, which as I have previously noted is maintained in a
collaborative effort through the CRC. So for the dental world really our only
checks and balances system is really through the CRC level at this point.

The medical system uses an interaction of procedure and diagnostic codes
for billing and for transaction purposes and as you know ICD-9 is maintained by
the government in an open process. The ADA has proposed SNODENT for diagnostic
information if required on dental claims. I will discuss our opinion about its
suitability in a minute, but I’d like to point out now that SNODENT code set is
maintained solely by the ADA, however we kind of heard some updates that at
least the ADA intends on including in some form some other groups, including
payers. But we would kind of make the argument there is really no system of
checks and balances or impartial party for maintenance of this important dental
diagnostic code set as there is currently in the medical world.

Our rationale is as follows. There’s been a great deal of discussion about
designated standard maintenance organizations regarding the adoption of dental
procedure code modifiers or diagnostic codes to provide a reason for the
specific treatment. And I kind of have to say that, just think about that, all
we receive on dental claims is a treatment code and so and very often it’s just
not evident by a particular procedure is really being done or even under what
circumstances the service is being rendered. Therefore in the dental world text
notes and attachments kind of take on more of a critical role because we really
don’t know why a service is being done or under what circumstances. The dental
payer groups find that diagnostic information is critical in order to
adjudicate many claims automatically and to manage our programs.

We should also note, too, that even the IRS kind of stipulates that dental
benefits really should not go towards services that are cosmetic in nature, and
the Department of Labor further stipulates that emergency oriented dental
claims should be handled in a very expedited type manner. And neither of these
cases is that often indicated on the claim when you do not know, again, you
don’t have a diagnostic code or a clinical reason factored to it.

I kind of go on to list some of the advantages regarding diagnostic codes
in terms of efficiency, that it certainly would improve accuracy of claims,
lower administrative costs, decrease the claim turnaround time by 2.2, and
actually reduce administrative costs because certainly a paper claim just costs
more to adjudicate then an electronic one. As many as three percent of 77
million claims, about 2.3, have missing information that may lend themselves to
be codified if you had a diagnostic type code set. Another application would be
for fraud and disease management purposes, as well as for benefit design. That
sponsors of dental benefit plans would now have information to help construct
more quality and cost effective type plans for group purchasers.

The research community is interested as it would facilitate more effective
outcomes research, and truly identify those procedures that do work, that are
efficacious and those that are not for a given clinical condition.

We heard a little bit about claims attachments, diagnostic codes will
reduce or eliminate the need for claims attachments in many respects that
currently discourage dentists from submitting claims electronically. Again, as
many as six percent of 77 million claims undergo professional review and
another 2.3 again kind of have missing information. If you just kind of do a
little bit of math up to six percent of 77 million claims, some 4.6 million may
be impacted if you could kind of codify some of this missing information. And
then again if you just kind of extrapolate that to the entire dental benefits
world using Delta Dental Plan numbers over 18 million claims could be
efficiently adjudicated with appropriate diagnostic coding improvements. So
again, our main concern is really trying to adjudicate claims more efficiently,
more accurately, and increase the EDI rate.

The ADA has acknowledged the importance of diagnostic codes to providers
and payers in previous testimony, testified for example that SNODENT could
provide the mans for diagnostic coding, reliable diagnostic treatment outcomes
data, and for third party payers to eliminate the need for narrative
descriptions in attachment, and I’ve kind of noted that previous testimony.

When you look at SNODENT it’s very analogous to SNOMED in terms of its
granularity, in fact SNODENT was included in the National Library of Medicine
licensing of SNOMED for its use in the electronic health record. So I kind of
come back now to this issue of process and how it impacts this important dental
coding subset and how in this particular role in the success of administrative
simplification.

The ADA has expressed strong support for using the 6,000 SNODENT codes as
the proper diagnostic code set for dental procedures. However, the ADA has also
indicated the development and maintenance of these diagnostic codes would be
solely and entirely the purview of the ADA without substantive payer
representation or participation, however again we kind of heard a little bit of
update on that today. So they have also declared that it falls outside of the
current purview of the coder vision committee.

The 6,000 SNODENT codes raises concerns about achieving the goal of really
truly administrative simplification. The 6,000 really may not be appropriate
for that particular purpose, and it really appeared to at least Delta Dental
more suited for use by the research community and dental informatics then by
payers. For billing and transaction purposes we don’t really need 6,000, that
appears very, very complex, we feel they would really confuse the provider
world. And according to most payers when you talk to them, roughly 30 to 40
diagnostic type codes is really that’s all that’s truly kind of needed to
really again achieve the goals of administrative simplification.

Our urgent message to the committee today is that administrative
simplification can be advanced for dental claims with the efficient diagnostic
code set. Again, only 35 or 40 would be needed. Important debate must occur
among the dental payers and providers before SNODENT or any other diagnostic
code set or set of modifiers is adopted.

ICD-9 and ICD-10 codes are much more efficient in our perspective then
SNODENT, and either would be preferable for the purposes of claim transactions.
Although as a plan we have not completed our full assessment, ICD-9 diagnostic
codes are somewhat limited and outdated, and DDPA does believe that ICD-10 with
some changes is a needed improvement for medical and dental claims. Currently
dental payers have no diagnostic codes in use in claim transactions, and so in
our preliminary assessment we view the cost differential between implementing
ICD-9 or ICD-10 to really be actually the same, and currently we are undergoing
a process of developing a package of ICD change requests.

Because HIPAA includes statutory definition of a code set that includes
diagnostic codes DDPA strongly believes that the diagnostic code is part of the
national standard code set and any proposal to adopt diagnostic codes, such as
SNODENT, must be accomplished in an open process established under HIPAA. I
would note at this time that our primary objective or objection to the adoption
of SNODENT for medical record core technology is really rooted in cost and
availability concerns and it’s not that we wanted necessarily representation on
the maintenance committee. Our request for participation on that committee is
really a result of the ADA initiative to add SNODENT to the electronic claim
format.

In summary conclusion, the adoption of diagnostic codes would be an
important step forward in simplifying electronic transactions for dental
procedures. DDPA supports ICD-10 for dental claim transactions. And just as CDT
dental code system is now a national standard in the dental industry and
maintained through a balanced process, the adoption of any dental diagnostic
code as part of this national standard must be accomplished through the open
process required under HIPAA, and DDPA respectfully requests the committee’s
support in this matter.

Thank you very much for your attention.

DR. COHN: Well, I actually want to thank the testifiers for really
fascinating testimony, very enlightening and I think very interesting for us
all. I guess I would ask that perhaps, given that at least two of the three
discussion items that we’ve had, one was obviously the CRC process and
licensing fees, seem to be at least I’m hearing sort of on the edge of being
resolved, I think two years after they were first brought up to the
subcommittee. I don’t know that we need to take time to discuss it but I think
we would all look forward to a letter, assuming the successful resolution of
those issues, just to indeed inform us that indeed that issue has been resolved
so that we can sort of take it off of our to do activities and issues to watch.
So I guess we would hope for that and we’ll obviously keep our fingers crossed
on that.

Now obviously I think everyone has a number of questions about SNODENT and
I’ll sort of defer to our other subcommittee members to sort of begin to delve
into that, and staff. I would observe that I’m hearing sort of an interesting
tangle of discussion here, and indeed I think obviously sort of reflecting on
this when we put this together, which was that I think when we were originally
talking about SNODENT we were sort of thinking about a clinical terminology
that would be used primarily within the context of a dental electronic health
record. And I’ve got to tell you I was informed in this conversation that I
always presumed that SNODENT, like SNOMED, handled really all aspects of
expression in dentistry as opposed to being just a diagnostic code, so I’ve
actually learned something from this presentation. But obviously what’s coming
forward is the issue really that, in this conversation, that there really is no
diagnostic code for dentistry and is it just used for an electronic health
record, or should it be part of a claims transactions, I mean where do all
these things fit together and so this is all sort of tightly bundled together
in the conversation. So I’m just observing that we’re hearing about three or
four things sort of simultaneously without trying to unwrap them all and
disambiguate them all, but hopefully we’ll have a chance to talk about that in
the questions.

Now Steve did you have a few questions to start off with them, and then
Jeff, and I see Clem also in line and then Stan, oh, and Marjorie.

DR. STEINDEL: Yes, I have some specific questions regarding SNODENT and its
legal relationship with the College of American Pathologists, the ADA
relationship with the college, and its inclusion in SNOMED. And I’m coming at
this from my position as CDC liaison to the SNOMED editorial board and I have
been in that position for probably on the order of six plus years and second,
as part of the key government negotiating team on the SNOMED license from its
inception, in both of those positions the college has always presented the
dental terminology content as integral to SNOMED, that it was provided to the
ADA and they have an agreement with the ADA to use it. Consequently it was our
assumption when we entered into the negotiations that this terminology, the
SNODENT terminology, would be part of the SNOMED package that was transmitted
to the government, and indeed it is and should be appearing for public
availability in the UMLS in the neat future.

With that as a preamble there are two things that arise from your
testimony. The first is you note that you have a ten year agreement with the
college on this. What happens with the dental content at the end of that ten
year agreement?

DR. GUAY: I would anticipate that it would be extended, and the ADA
generally does not enter into ten year agreements with anybody, our agreements
are usually one year or two years or three years, but we have such confidence
in the CAP relationship the initial contract was for ten years so we anticipate
it being renewed, the Lord only knows that. But I’ll tell you the ADA and the
CAP are going forward on an international basis with SNODENT code as part of
the SNOMED code besides in the United States. So our relationship with SNOMED
and of the CAP is growing rather then shrinking.

DR. STEINDEL: Okay, I’m encouraged to hear that, thank you. The second part
of that is that if for some reason, and there’s absolutely no intention on
anybody’s part, the college’s part, the government’s part, or anyone else’s
part, but the agreement was specifically written to protect the investment of
the government that in case for some reason this agreement should be terminated
by either party, the last version of SNOMED would turn over to the government
to be used as it is now, and that would include the SNODENT terms, and you are
comfortable with that portion of the agreement.

DR. GUAY: This is my first knowledge of that but on, and I read quite a bit
about it, my guess is that there, it’s fine. What is happening now is happening
now. There’s an agreement to perpetuate today’s situation in the future, I
think that that’s okay. I really don’t, I don’t really foresee any friction
between the two organizations.

DR. STEINDEL: Okay, thank you for clearing that up. I think there are some
other questions as Dr. Cohn just alluded to concerning SNOMED, SNODENT, and
HIPAA code sets and diagnostic purposes, etc., which I think other committee
members will address but I wanted to clear up the specific thing with regard to
the federal license. Thank you.

DR. GUAY: And maybe add one more thing because this sort of fills out the
picture, there’s been a discussion with CAP and in CAP about the availability
of the SNOMED, including SNODENT, through the National Library of Medicine at
no cost to use in the United States. And when we first saw that we were a
little bit distressed by that but we’re no longer distressed by that because
what, if you look at SNOMED as a total code, as I said earlier, the SNODENT
terms are not in a chapter called SNODENT, they’re dispersed through any one of
the systems where the codes are derived. And there are a number of codes from
SNOMED into SNODENT, a number of dental codes from SNODENT into SNOMED, so the
service that the ADA will perform will be to extract the subset of the SNOMED
code called SNODENT and that will be the product in the marketplace.

DR. STEINDEL: Thank you.

DR. COHN: Okay, Jeff next then Clem.

MR. BLAIR: Up until the availability of SNODENT what codes were payers
using to reflect diagnosis?

DR. GUAY: The answer is none, there’s never been a request or a requirement
for dental claims transactions for a diagnosis or diagnostic code. To this day
there’s not either.

DR. ADAMS: They’re not being used now either, SNODENT is not being used by
the third party payers —

MR. BLAIR: So you haven’t used diagnostic codes at all.

DR. ADAMS: No.

MR. BLAIR: When the NCVHS went through the process of trying to select a
core set of clinical data terminology standards or PMRI standards the process
that we used, not necessarily saying that it’s right or wrong, but the process
that we used was to gather information from the code set developers, and to
hear from the users of the code sets and I don’t really recall, when we heard
from users we just assumed that all of the users of these code sets were either
vendors of electronic health record systems or health care providers. I don’t
recall that we ever checked with payers because we were inferring that the
clinical data terminologies that we’re looking at would be mapped to existing
diagnosis and procedure code sets that were previously defined under HIPAA. So
one of the things that I’m thinking of here is that the use of SNODENT I’m
thinking of as primarily being a use for patient care, for clinical research,
and that it would have a secondary use in feeding into the reimbursement
process. And Ed, you mentioned that all you really need is maybe a roll-up into
about 30 codes and maybe that makes more sense for the reimbursement process,
doesn’t need the 6,000 SNODENT codes, but the other uses of SNODENT require the
6,000 uses. So maybe there has to be a bridge, an intermediate step as there is
with acute care and ambulatory care in medicine, to a billing code set, which
apparently doesn’t exist, and maybe part of the problem here is to infer that
SNODENT would be a billing code set and maybe if you could wind up looking at
it instead as a clinical code set and still consider that there is a lack of a
billing code set for diagnosis that needs to be created, and then have SNODENT
mapped to that billing code set, maybe that could help resolve the issue.

DR. COHN: Dr. Guay?

DR. GUAY: We have a, first of all, as happens in this conversation
historically the two systems are intermingled, they’re two separate systems.
You’ve identified clearly that there are different needs maybe for codes but in
talking about the SNODENT diagnostic coding system in the context of the
clinical patient record, electronic individual patient record, and that’s what
the ADA is seeking, is to us clear, now on a practical basis with our procedure
codes. Now with our procedure codes there are 600 procedure codes or so. We
have a condensation that we publish with our manual, and this is one of the
services of the manual, of the most frequently used codes so that in dentistry
particularly I would have to guess in my clinical experience there probably are
less then ten diagnostic codes that are used every single day in the dentist
office, carries(?), periodontal disease, whatever, because the scope is
ordinary daily general practice dentistry is limited to a small number. And so
we publish with our entire procedure codes a summation of the most frequently
used codes so that office administrators don’t have to go through the book
every day looking for those few codes that are used on a repetitive basis.

Now electronically that’s simple to do, and we’re talking about moving to
an electronic environment, and it’s a simple thing to identify those codes that
are used most frequently. On the other hand most frequently for reimbursement
purposes is different then most frequently for diagnostic purposes. So I think
it would be not too difficult and it would seem to follow logically that were
diagnostic codes ever to be required or asked for in health care transactions
that the ADA in their process that they followed that they did for the
procedure codes would publish a small number of frequently used diagnostic
codes in every day dentistry. So it’s a practical solution to a problem that
would be more complex then it is.

DR. COHN: Other comments? Did you want to make a comment on this one?

MS. GREENBERG: Well, I just wasn’t sure that people, everyone was aware of
the process that’s been going on starting with the December meeting of the
ICD-9-CM Coordination and Maintenance Committee, and continuing for the next
meeting, and I believe it’s in April or May, and actually I’ve been emailing
here with Donna Pickett who due to the weather was unable to get to the, she
helped, she may have spoken with several of you, I think she helped set up this
part of the agenda. She is listening in on the internet —

DR. COHN: Well, give her our regards.

MS. GREENBERG: Hi Donna. I haven’t gotten a response, she sent me an email
saying, and I was of the same impression, that didn’t sound like people were
necessarily aware of the work that’s going on to expand ICD-9-CM for dental
diagnoses. I was actually at the December Coordination and Maintenance
Committee meeting and a number of recommendations came forward for updating and
expanding those codes for administrative reimbursement and related purposes,
obviously not for the clinical record. And I believe most of those are being
incorporated into the addendum for the 2004 for ICD-9-CM and also there are
additional requests that I think will be favorably entertained at the next
meeting. And of course anything that goes into 9-CM would go into 10-CM if it
isn’t already there. So I think the process is what I had asked Donna and
haven’t been able to get a response yet, is who was leading that effort because
I’m not quite sure though it sounds like Delta has been involved with it
somewhat. So I think the process is underway to get dental codes into the
current code set that is used for diagnoses under HIPAA administrative
transactions.

MR. BLAIR: Well, the other piece of the puzzle then would be if SNODENT as
part of SNOMED is being mapped by the NLM to this expansion of ICD-9, then the
mapping is there, to the billing codes.

MS. GREENBERG: It would be.

DR. COHN: And maybe I should just ask almost a more fundamental question
because I think that there’s, once again, there’s three or four undercurrents
going on. One of them is what to use for a clinical terminology, and obviously
is trying to make what you do exactly how we’ve conceptualized how the rest of
the health care world we have perceived it, and it may or may not work for
dentistry. But I guess I’m sort of wondering, I’m sort of hearing and maybe
this is an undercurrent with ICD and with your testimony, is the intent of
dentistry to start requiring dental codes, diagnostic codes on dental claims?
That’s seem to me what you’re all dancing around with because I’m hearing that
you don’t have one, it sounds like at least some of you perceive that there’s a
need for one, you’re wondering whether SNODENT is that or whether it’s
something else, and you’re sort of talking about it, there’s going to be a
modifier to a CRC code, I mean to a CPT code or is it going to be something
else, is there general agreement by all of you that the industry would work
better and the billing and claims and administrative simplification pieces
would work well? Is that really what we’re talking about at least on one level?
Ed, do you have a comment?

DR. SCHOOLEY: I would not go to the point and say that there’s general
consensus across the industry any way in terms of the need to have a diagnostic
code, but I will tell you that in our initial work investigating modifier codes
or having a clinical reason for a treatment code there is a lot of interest by
plans, by many major plans, to have the availability of a diagnostic code set
for some of the reasons I kind of mentioned. Right now they have none, right
now they cannot even choose to use a diagnostic code set to improve the
adjudication of claims, so our premise is trying to get a standardized
diagnostic code set out there at least available for plans to use who want, so
choose to use them for their business needs.

DR. COHN: Roger?

DR. ADAMS: Yes, I think there are a couple of things to realize the
difference between health and dental. Many of the plans and many of our members
are independent dental plans only, they don’t use a medical processing system
to process their claims, so they don’t even have the capability for putting in
the diagnostic code in their claims processing system. So if you implement and
mandate a diagnostic code there’s going to be a tremendous cost associated by
many plans to implement just to be able to process the code. So HIPAA was a
tremendous impact for a lot of these companies to start becoming HIPAA
compliant, but now you throw on and what we’re getting in feedback is a
tremendous concern with the cost of implementing a diagnostic code.

The second comment I’d like to make is I’m hearing Al talking about
electronic patient record, which is a totally, fine, I can understand that from
the complexity of that many codes if you’re really getting in, I mean if I
start going to my pathology and you want to have diagnostic codes, I’ll come up
with 6,000 different variations of a fiberosteous(?) lesion within the
mandible, I mean depending on how you want to split the hair on diagnosis. But
when we start talking about clinical diagnosis for paying claims you can take
the most highly utilized codes, that’s one way of looking at it, but that’s
still not a diagnosis, that’s just the utilization of code. I think what I
would submit is that there is the possibility that the electronic claim piece
is a total separate animal from the actual processing piece, much more like
Jeff has talked about, and that we need to have an industry coalition put
together to recommend the diagnostic code proposal to where we then can make
certain that that fits from a payer perspective and from a clinical perspective
so that we don’t overwhelm a payer’s system and cost, and that we also come up
with a legitimate, and I agree with Ed, as I’m just sitting here grinding
through my head, probably 35 diagnostic codes would be reasonable in dental, it
might be 40, it might be 20, whatever, a small number, but I think that that
has to be developed with the significant input of the payer community for what,
if we get mandated that it’s going to shut down many companies just with the
cost of trying to do that in a short period of time. But if there’s enough time
and they see this coming down then there’s not going to be an interruption of
care and it will keep every plan in a competitive market. Does that make sense?

DR. COHN: Well, I think you’ve said two things that are sort of opposed,
one is that you’re afraid of diagnoses but it sounds to me like you’re
basically in favor of a small amount of diagnoses —

DR. ADAMS: We’re not afraid of it, we just don’t want to see it come down
in a sudden, and I think from a payer community, putting my NADP hat on it, we
definitely need via the table because we understand the complexities of
implementing that type of a system in a processing modality that doesn’t exist.

DR. COHN: Okay, before we move on Dr. McDonald, Dr. Guay, what do you think
we’re talking about here?

DR. GUAY: Well, I’m going to ask you the same question. Are we off now, my
speculation is that you really love SNODENT as a clinical descriptor in the
patient health record.

DR. COHN: That’s what you think we like.

DR. GUAY: I’m hoping that’s what you like.

DR. COHN: Well, what is it that you want —

DR. GUAY: If we can close that book again and say now we’re talking about a
dental transaction piece apart from the patient record that would be usable if
the industry ever asks for diagnoses and it’s not in our power to do that.
You’ve heard them say that’s so so. So what I’m saying and I said earlier, the
American Dental Association has absolutely no power to tell industry what they
need for the adjudication of claims. If they say they need this or that that’s
their business, I mean we’re not in that business. We’re in the business —

DR. ADAMS: [Comment off microphone.]

DR. GUAY: — CDT is not a diagnostic —

DR. ADAMS: No, but what we hear from the payer community is that the
evolution of SNOMED all of a sudden becomes a beast that we are now obligated
to pay claims to just like CDT came in and evolved in that sense. So that’s an
environment that makes us highly nervous. Now if it’s just purely an electronic
patient record that is not going to be impacted and mandated to be used in the
payment of claims, we don’t have any problem with that.

DR. GUAY: Who would mandate that you had to have diagnostic codes in the
claims procedure payment transactions, who would mandate that?

DR. COHN: Probably the Secretary of HHS, I mean if anybody was going to
mandate it, through rule making I mean —

DR. GUAY: Would the Secretary of HHS say in order to pay dental claims
you’ve got to have a diagnostic code?

DR. COHN: I’m actually asking the industry what you want. Obviously
dentistry, and then I’ll let Dr. McDonald because he’s been very patient, but
clearly dentistry is a different beast then medicine in the sense that medicine
is typically has had diagnostic codes that have been used for billing and used
for administrative transactions, and the clinical diagnostic work that we’ve
been doing has been to a degree of granularity for clinical care. Dentistry
seems to be in the position where you don’t really have much in any way of
diagnoses in your area and so I think it leaves open the question of if you
have a diagnostic code system how it will be used, which I think is what you’re
sort of asking, is it just clinical, is it administrative, is it both, and I
think that’s sort of what you’re bringing to the table. So I think I’m hearing
that at least all of you are sort of, might be more comfortable with SNODENT if
it were just used in electronic health records but it does leave open the
question of what do you do on a claim or do you even put a diagnosis on a
claim, and that’s really a question for the industry.

MR. BLAIR: Just in case it wasn’t, Ed, in case you were not aware, when the
NCVHS recommended SNOMED as part of a core set of PMRI terminologies, it did
not recommend it for payment, it recommended it for clinical use.

DR. COHN: Well, Jeff, I’m not trying to answer that question, I’m just sort
of observing the landscape. Now Dr. McDonald has been very patient.

DR. GUAY: Trying to get my train of thought back. I think the last thing I
said was that the need for including diagnostic information in the dental
transaction is solely within the power of the payer industry, not the power of
the profession. The track record has been for 30 some years they’ve gone along
probably relatively well never asking that question. So it sort of raises in my
mind what is the deal now, but that’s not our business as I said earlier. You’d
asked about ICD-9 and the procedure process for maintenance of ICD-9, I’ve seen
ICD-9, I’ve seen the recommendations going forward, and there’s a couple terms
in there that I’m, I’ve been a dentist for a long time and I think a good
dentist. There was terminology that I had no idea what they were talking about.
I went to all the existing dictionaries in our library, terms not included
anywhere on the medical dictionaries in our library. The only way I got to
figure out what they were talking about was they had an explainer, explanation
of what the terminology was, so that is not a user friendly contemporary coding
system. It has archaic terms, it’s not hierarchical, it misses things, it is
very difficult. So that’s why the ADA when they were looking to do a coding
system our first inclination was why don’t we just build upon an existing
coding system, why start from scratch. And the first place we went was the ICD
series and we found it unacceptable, and so this is a whole genesis of the
development of the SNODENT as part of the SNOMED hierarchical logical system.

DR. COHN: Marjorie, please.

MS. GREENBERG: My emails are coming in fast and furiously here, I guess
it’s the blessing and the curse —

Okay, apparently it was the University of Illinois School of Dentistry that
brought forward the request for new codes to ICD-9-CM, but there were
supporting letters received from others in the dental community, and I’m trying
to find out who those were, but in any event there were 76 new dental codes
that were proposed for October 2003 and more being proposed, which would be
implemented in 2005 at some time. I think she means October 2004.

The point is that this process is going on right now and it needs your
participation, these three groups, as well as others in the dental community.
We have had some input obviously but it appears not sufficient maybe. And I
believe that the addenda is either posted on the NCHS website or will be posted
very shortly, and so we really need, there’s another short comment period
because there’s a whole process by which we have to get new codes into ICD-9-CM
that will then be part of the 2004 addenda and then are used in the DRGs and
everything else. I realize that these dental codes would not be used for that
purpose but before we add these codes I would want to make sure that we have
had full, I mean these are open meetings as you know about but it snowed the
day the 76 codes were presented.

So anyway, I hope you don’t mind if I use this opportunity to encourage
people to go to the NCHS, www.cdc.gov/nchs classifications website and
see what has been proposed and let us know whether you support this or not. And
I also was just going to say, we were having a little bar here, that I’m old
enough that I remember when diagnostic codes were not required for outpatient
and physician claims, and of course that decision then was changed by Medicare.
As we know Medicare does not cover dental but Medicaid does and I understand
that they’ve been using local codes so some type of a movement towards a
national code set does sound like it would be desirable and obviously all the
interested stakeholders need to be involved.

DR. COHN: No, I think the fact that I’m looking at three presenters, who I
think are key to this sort of activity, who at least to my understanding don’t
seem to be aware of it, obviously tells me there needs to be better
communication and interaction, but certainly we would hope that you would all
participate and review these codes. Dr. Schooley, I’d actually like to allow
Dr. McDonald to ask a question.

DR. MCDONALD: Thank you. Some of the questions kind of got answered but it
was just clarification and then I wanted to ask a real question. But
originally, the 40 codes you were talking about were diagnostic codes, not
procedure codes, correct?

DR. ADAMS: Correct.

DR. MCDONALD: And the procedure codes now are the dental procedure codes
and there’s 600 of them or something like that, right? And when you’re talking
about ICD-10 which version, ICD-10-CM, the diagnostic codes, or PCS, the
procedure codes? You said ICD-10 might work for us and I wasn’t sure in which
context that statement was made.

DR. SCHOOLEY: Within the Delta organization we have developed actually a
task force to assess ICD-9 and ICD-10, and we did use the CM version —

DR. MCDONALD: For diagnostic codes.

DR. SCHOOLEY: — started to look at and started to identify business needs
and then gaps in the current diagnostic coding system, and what would kind of
be needed, and we’re going to be putting together kind of a package of
additional items.

DR. MCDONALD: Then having kind of got oriented clearly, the question really
related to how harmonious the decision really was, the one that Simon thought
we didn’t have to ask. And I think it isn’t from what I heard from the
succeeding discussion. Let me interpret what I think I hear, I think I hear
that sort of the larger industry would like to have, they may like to have some
diagnostic codes because it might help adjudication, but they’d like to have a
modest set and then with various participants in the development, is what I
heard, and so in that context I think the word about the SNODENT being sort of
the tail under the tent or something like that. Is that fair? So the economic
issues are still prevalent or is it just really can we get what we need instead
of something else? You don’t have to answer me directly I guess but that’s
really what I —

DR. SCHOOLEY: I would just like to comment that DDPA’s main concern is
really the open process aspect of it and we really don’t know exactly what that
truly meant before coming here today, whether that meant just merely attending
a meeting, whether it just meant providing some input, or whether it really
meant more of a direct participation, being at the table, having a vote, and
whether there is a good, again balanced, and check system if you will that you
have on the medical side.

DR. ADAMS: And I would, our feeling is exactly the same.

DR. MCDONALD: So tomorrow a document is not going to come out that’s going
to go well, it’s all pretty sweet and roses time.

DR. COHN: Stan, I think you’re next. We’ll just try to keep it in line
here.

DR. HUFF: I’m just trying to make sure I understand the history and then
sort of the current governance of SNOMED, or SNODENT terminology. SNODENT
existed as an independent corpus before you started collaborating with SNOMED?

DR. GUAY: SNODENT was in a developmental process, and we developed SNODENT
in conjunction with SNOMED, in other words the exact process is the Code NIC
committee I talked to you about, was made up of representatives from each of
the specialties of dentistry plus general dentistry and some ADA people, they
drafted up in each of the areas of dentistry the conditions, the diagnoses,
submitted them to the SNOMED people, who then added some additions and put
SNOMED codes onto the list that the ADA had supplied to them of dental
diagnoses. And when that was done that was SNODENT, the combination of
terminology developed by the ADA, some added by SNOMED people, and SNOMED
codes, that became SNODENT.

DR. HUFF: Okay. And what, I mean was discussion about CRC and maintenance
of CDT, what is your process going forward for maintenance of SNODENT?

DR. GUAY: The process, first of all SNODENT has, as I testified earlier,
has been on the shelf since ’99 and it was brought off the shelf with the
Secretary’s request for submission of codes for designation as a core
terminology. And so from the initial development of SNODENT, when it was
finished in ’99, there’s been no work on that at all. Now the ADA is saying now
that the code the committee has been going on all these years, the proposal is
that there will be payers put on the Code NIC committee, which will meet and
discuss all recommendations for changes to SNODENT from any interested party.
That will then go on to our council for their approval, and then will go on to
the SNOMED editorial board for inclusion in the overall SNOMED, which includes
the SNODENT.

DR. HUFF: So, just summarize for me again, who’s on the committee that
you’re proposing? Is that the same committee as the code committee that manages
CDT or is it —

DR. GUAY: Two different worlds.

DR. HUFF: — entirely different.

DR. GUAY: North hemisphere, south hemisphere, the crossing over, somehow we
got to the equator thicker. The two are totally different —

DR. HUFF: And who are the people who would be on the SNODENT committee
then?

DR. GUAY: SNODENT committee is comprised right now, is composed of
representatives from each of the recognized specialties of dentistry, eight,
from the Academy of General Dentistry representative, and representatives from
the councils that manage practices in the ADA, dental practice, dental benefit
programs. We’ve proposed to add to that committee representatives from payer
organizations. We’ll still be called the Code NIC, it will be expanded by
adding payers to that. We’ll have the same vote on that committee as anybody
else has, one vote each.

DR. HUFF: And it’s been asserted that “SNODENT is unreleased” —

DR. GUAY: That’s true, it’s available from the National Library of Medicine
for anybody in the United States that wants to —

DR. HUFF: How would I recognize it within the UMLS metathesaurus?

DR. GUAY: It’s as I said earlier, there’s not a section called SNODENT, the
codes are imbedded in each of the sections by systems, that when pulled
together would become, and what the ADA would do is combine those, or sort them
out and list them as a subset of —

DR. HUFF: But right now that pulled together set doesn’t exist.

DR. GUAY: It does exist, we have that.

DR. HUFF: You have it?

DR. GUAY: We do. We made it available to Delta, they didn’t look at it. We
have probably five or six or seven sites now using this, mostly our
universities, using this SNODENT systems in a couple years.

DR. MCDONALD: Will that be free?

DR. GUAY: Pardon me?

DR. MCDONALD: Will that be free?

DR. GUAY: The SNODENT part extracted will not be free. If you wanted the
plastic surgery set from SNOMED, that’s not free either. You can extract it,
the subset. This has all been a long discussion with CAP about what is the
relationship between us and the freely available code at the National Library
of Medicine and that’s been resolved because they were doing the same thing
with their own people about what could they do with the SNOMED code now that
it’s available at the National Library of Medicine, can they have sub-products
that they can sell and the answer is, in their summation is yes.

DR. COHN: Stan have we addressed —

DR. HUFF: Final question. Is the content of SNODENT restricted to
diagnoses, or does it have finding information? The distinction I’m making is
finding information would be, I mean I’m not smart about dentistry but teeth
color or descriptive properties of teeth, and the wear and how much your gums
bleed, that’s sort of stuff is in there?

DR. GUAY: It has some findings but mostly are diagnoses, sometimes the
findings in diagnoses, there’s not a clear line between them, they are
primarily diagnoses symptoms and some findings, mostly diagnoses.

DR. HUFF: Thank you.

DR. COHN: Okay, thank you. Michael and then Steve.

DR. FITZMAURICE: As with a lot of hearings this has been really informative
and it’s like looking at a microcosm of the economy. I see some people talking
maybe subtly about premiums, giving health plans a fair opportunity for profit,
and we’re talking about the tools they use. I hear people subtly talking about
payment to providers and fair opportunities for income, but consumers would say
they want services, that is a fair opportunity to choose providers, provider
services with payer health plan premiums. There’s a lot of desirable
characteristics we probably could agree on, maybe not all of them, we want
efficiency in the process, we want open representation of those with direct and
material interests. We want an accurate description of the services and the
patient outcomes. It gets involved in technology, diagnoses, procedures,
because we want to advance medical knowledge for the benefit of the patients.

A lot of this the marketplace is going to determine, it’s not going to be a
Secretary decision, the marketplace determines payment schedules, dental health
plans, benefit coverage decisions, adjudication, this is essentially the
weighing of the benefits and costs to all parties. Within our framework there’s
a National Health Information Infrastructure which is a vision, we have to deal
in the world of reality, so we push for greater efficiency, greater advancement
of medical and dental knowledge and technology, and we want the application of
this knowledge and associated techniques for the benefit of the patient.

What I see you going through, and it’s a very good process you have, you’re
talking with each other, you’re expressing the incentives that you have in
trying to work it out. Nothing every comes to us perfectly but we can see where
you’re going and I think the process you have so far has been a very good
process with a lot of good will on both sides. It’s kind of privilege to see
this microcosm at work, and I wish you luck.

DR. COHN: So that’s a comment.

DR. FITZMAURICE: That’s a comment.

DR. COHN: Steve and then Clem and then I’m going to try to put things
together here.

DR. STEINDEL: I have a for information question of you. We’ve mentioned a
lot of committees and groups but there is a dental DSMO, and what is the
constituency of that group?

DR. GUAY: I can’t answer that question, maybe Frank, he participates in the
day to day operations, if that’s okay.

DR. ACORDY: Frank Acordy from the American Dental Association. I believe
you’re referring to the ADA’s Dental Content Committee. The constituency of the
Dental Content Committee, and if my memory fails I beg forgiveness, it’s
comprised of representatives from the National Uniform Billing Committee, the
National Uniform Claim Committee, the Delta Dental Plans Association, the
Workgroup for Electronic Data Interchange, AAHP/HIAA, the Blue Cross and Blue
Shield Association, and four representatives from the American Dental
Association, excuse me, five representatives from the American Dental
Association. I think that should, excuse me, and the Centers for Medicare and
Medicaid Services. I believe that total is 13, if not please correct me.

DR. STEINDEL: Thank you, I was curious about that because of course that’s
one way to get input into the HIPAA process and I just wanted to see how
broadly constituted the group was.

DR. COHN: Kepa.

DR. ZUBELDIA: Thank you. Let me express some reservations from this
meeting, I’ve been kind of on the sideline listening in. It seems like SNODENT
is a clinical terminology, it’s more then diagnostics, it’s a clinical
terminology, of which some of the terms are diagnostics. It also seems that
nobody wants to have a requirement for a diagnosis code on every dental claims,
at least I think that’s coming out pretty clear, it has been expressed both by
payers and the ADA, that it’s not necessary, it’s worked like that for 30 years
and the payers are concerned that they may be overwhelmed with a diagnosis code
on every claim.

But it also, I’ve heard that the payers may need additional codes,
additional codes to identify whether a claim is the result of a cosmetic
procedure or it’s an accident or a prophylactic, and some of those codes may be
diagnosis codes, but some of them may be different from diagnosis codes, maybe
a code that says this is a cosmetic procedure independent of a diagnosis.

On the other hand the claim itself, the 837 claim as we know it today, the
dental claim, even though it has room for diagnosis codes, the implementation
guide has specifically removed those elements and marked them as not used. And
I checked that out, and also there’s a section right next to the procedure code
for four modifiers that were initially opened as modifiers and in the addenda
were restricted to modifiers issued by the American Dental Association Code
Content Committee, I think the modifiers must be part of the CDT modifiers,
those are the only modifiers available. And as of today there are no modifiers
issued like the CDT, so you can only use certain modifiers that by the way
don’t exist.

It seems to me that adding diagnosis codes, even adding diagnosis codes to
the claim, whether they are ICD-9, ICD-10, or SNODENT, one satisfied the
problem if there is a problem. It seems like what I’ve heard expressed by the
Delta Dental Plans is that perhaps you need some codes but I suspect that
adding diagnosis wouldn’t tell you whether it was an accident or whether it was
a cosmetic procedure or a prophylactic procedure, or what the diagnosis was.

So perhaps this dialogue that you’ve started and that is going on perhaps
needs to look at the possibility of having some codes that could be useful by
the payers to satisfy their needs that they may have and perhaps even legal
needs in certain states to identify something for certain dental claims, that
are not necessarily just diagnosis codes, and perhaps you need to look at
something, I don’t know what, that could fit within the existing claims
structure and for a moment I’m going to call them modifiers. Because that fits
into the structure as we know it today and I’m not saying that they would be
equivalent to the modifiers that we use for the CPTs and HCPCS codes but it
could be a modifier for billing purposes only. And for billing purposes you may
want to give additional information in addition to the procedure code.

And if we look through the 837 claim telescope view, the thing that comes
is that there is a place for up to four modifiers that would modify a procedure
for billing purposes and leave the SNODENT terminology separate from this
battle that I think is very separate and distinct. It’s just my observations on
this.

DR. COHN: Yeah, and maybe I’m maybe speaking for some of the testifiers but
my understanding in the testimony was at least some discussion that those sorts
of modifiers had at least at one point been under consideration by your CRC —

PARTICIPANT: There was an ad hoc —

DR. COHN: — and it may be either on the table or off the table depending
on the workings of that group, that is correct isn’t it?

DR. GUAY: There’s several organizations, just two come to mind, that
proposed the modifiers to the procedure codes, and almost universally the
modifiers were diagnoses, didn’t deal with cosmetics or emergency or patient
circumstances or procedure circumstances, they were diagnosis. And so the
discussions with the committee is that a modifier to a procedure, we don’t
think so, it’s a diagnosis, nothing to do with the procedure per se.

DR. COHN: Sure, and I guess I would defer to the workings of the dental
community to figure out what they want to do with modifiers, though I think
that Kepa has his reasonable suggestion.

I wanted to sort of try to put things together because I think there’s a
number of to do’s for the people who have testified before us, and I’ll start
out and I think Clem may have an additional —

DR. MCDONALD A question, that’s what I have is a question.

DR. COHN: Oh, I’m sorry, please.

DR. MCDONALD: In terms of the subset I just wanted to understand how, I
guess ADA assumes that the big set is not going to be very conveniently used,
so most dentists or systems would want to have the subset. Is that an
assumption?

DR. GUAY: That’s my guess.

DR. MCDONALD: And then a question, could anyone else make such a subset or
would that be, the subset be copyright by the ADA?

DR. GUAY: I don’t know the answer to that question except that if it were a
piece of SNODENT, that’s copyrighted, and I think the agreement with the
Library respects copyrights.

DR. MCDONALD: Well, the challenge is is I think what the agreement says is
you must get it delivered as the whole UMLS, and the question is is it the net,
people will still have to pay for it to get it in a practical form, that would
be a disadvantage.

DR. COHN: Carol, do you have a question? Then I will try to put things
together and give everybody a lunch break. Please, go for it.

DR. BICKFORD: Carol Bickford, American Nurses Association. In this
discussion there are two groups that I haven’t heard as part of the discussion
and that is the educators, how are we preparing our dental practitioners and
how does the faculty in the schools of dentistry help them learn about dental
codes and standards in relation to that? And the second group are research,
because if we’re looking at outcomes, that’s based on evidence based practice
in research and so how are they able to put all this stuff together and
aggregate it and count it and do the checks and balances. So I’m raising those
as folks that I haven’t heard in this discussion as being partners in the
decision making and the development process.

DR. COHN: Thank you.

DR. GUAY: Well we have, I think there’s five, don’t hold me to that number,
schools using SNODENT in their clinics, and there’s one school, I’m sorry, I
can’t remember who is going to totally electronic records in their clinics and
they’re using SNODENT. We’re in discussion with the CDC about CDC using SNODENT
as an epidemiological —

DR. COHN: Well, thank you, I think Steve has hopefully a final follow-up to
Dr. McDonald’s question and then maybe we can once again try to put this
together and figure out the next steps.

DR. STEINDEL: Yes, this gets back to the first question that I asked
concerning the federal license. The federal government did not license SNODENT,
it licensed SNOMED, and SNODENT is part of the content, an unrecognizable part
of the content of SNOMED as far as we receive it. And consequently the federal
license governs what we can do with the SNODENT content within the, as put into
the UMLS and as we would use it from the UMLS. And since we can’t distinguish
it as a product of the ADA we would be able to use it for subsetting, etc., as
we would be able to use any other part of SNOMED. And that’s what I was trying
to clarify earlier in part. And that’s why I was curious about did the
National, the agreement between the College of American Pathologists and the
National Library of Medicine, from the ADA’s point of view, properly represent
the intellectual property rights of SNODENT. Was the college free to do what
they did with it? And if they are not then I think we have some problems that
we need to discuss, both with the ADA and with the college because it’s the
government’s assumption that we can use it as we would any other portion of
SNOMED.

DR. GUAY: My legal training was at Tuft’s Dental School, so I’m sort of
speaking away from my sort of expertise. We’ve had discussions with CAP about
that because we had the same question that you pose, and we were told that we
under the arrangements were free to do what I said that we would consider
doing. And apparently, I’m not speaking for them but apparently they feel the
same opportunities, that providing materials that make the utility of the code
more user friendly, that they’re free to do that —

DR. STEINDEL: Yes.

DR. GUAY: That’s the assumption that we’re going under. And if we’re wrong
that will be another battle going on between —

DR. STEINDEL: I mean my position at CDC would be that the group at CDC who
was thinking about using SNODENT, if they’re thinking about entering into any
type of payment relationship for just the codes, now not anything peripheral to
that to make it easier to use, etc., I would say we can get those codes for
free through the UMLS license agreement, which is what we’re planning to do
with all other forms of SNOMED.

DR. COHN: Okay, let’s try to put this together, I think that this may not
be as easy as I thought a couple of minutes ago because clearly there’s a
number of different currents going on, and I think a number of to do’s really
for our esteemed presenters. I really want to thank you all for really what’s
been a fascinating set of discussions, some of them sort of hard to pull apart
because they’re so tightly intertwined.

Obviously I start off the conversation by sort of asking, knowing that the
CRC membership and the license fee issue is sort of sounds like is close to
some sort of conclusion. Obviously you have the subcommittee informed of when
that was resolved and obviously we would still very much like that.

I’m obviously hearing that there’s needs in dentistry for at least for some
undefined purpose some limited set of administrative codes for diagnoses, I
think I’m sort of hearing that and it will be determined obviously by the
dental community exactly how they would be used. Now as we talk about that it
certainly sounds like there’s an independent activity going on that it sounds
to me like you may not have been aware of relating to the world of ICD-9 in
terms of additions to ICD-9 and that should certainly be something that you’re
all evaluating.

Now we do obviously understand that obviously on one hand the ICD-9
Coordination and Maintenance Committee is an open process. On the other hand
probably it’s not something that you all follow really closely because
generally it probably doesn’t have a lot to do with dentistry, or at least that
you don’t perceive that it does but it certainly recognizing the work going on,
it’s something that it sounds like you all need to be reviewing and seeing how
it might in some way meet your needs.

MS. GREENBERG: I’m giving each of them the website so they can —

DR. COHN: Okay, the website and maybe Donna Pickett’s phone number so they
can call her to ask about it. So that’s certainly something that you all ought
to be doing, recognizing that you seem to have dual needs.

Now I’m also hearing issues about SNODENT and its applicability, and it
sounds like there’s a number of issues still outstanding relating to contracts
and specific uses that probably need to be dealt with with the federal
government I think before we can start making any comments about its
applicability and usefulness as a national standard in a clinical domain for
the purposes of an electronic dental record or something like that but we’ll be
looking forward to getting some of those clarified and hopefully we can make
some further statements.

Now as part of that obviously I think it’s very refreshing actually to hear
the payer community engaged in these conversations. I’m actually sort of
looking at this and sort of thinking back to our PMRI discussions and the truth
is is that the payer community in health care, though I represent sort of both
in the world of managed care, has probably not been as engaged as they ought to
be, and you’re actually showing us a very interesting model where the payer
community really does, is aware of the importance of clinical diagnoses, and so
we obviously, from my view the idea of a more open process where the payers and
providers are working together around the concept of clinical diagnoses and
findings are, it’s obviously refreshing and something that we obviously
encourage.

Now we would look forward to hearing from you exactly how that works out
and whether as you continue discussion whether it’s as open a process as you
would like, because I think openness is probably, and it’s openness and
inclusiveness in terms of the conversation, so we would look forward to future
communication from you all about how well that’s working.

I think beyond that, I’m not sure, I probably am missing some other key
areas but I mean Kepa obviously brings up the issue of how the electronic
implementation guides work in with any of your future visions, and certainly I
think you’re hearing that there are clearly constraints based on what
implementation guides look like on how any of these pieces fit into electronic
transactions, which is one of the things that you’re all speaking as being in
favor of, wanting to have work easier so that you can do less claims
attachments. And certainly the choices that you all have are to talk with the
X-12 clinical, dental, Kepa, help me with this one, is there a separate X-12
group that deals with this one? Okay, well basically to have future changes
made in the implementation guides to enable at least on a situational basis
diagnoses in a way that might be helpful to the industry, or perceive something
that you could do now which is a modifier, but that’s really something that the
industry needs to decide and it’s really part of your near term and longer term
strategy.

Now have I missed anything? Is there any other to do’s that we’re asking
from this group? Clearly you’ve got a lot of work to do, I think it’s wonderful
that we’re all talking about it. Do you have any final thoughts? I mean we’ve
obviously been hitting you pretty hard with questions and really appreciate
your openness in terms of the discussion. Dr. Guay, any final comments?

DR. GUAY: I spoke to Kepa earlier this morning about the attachments
situation and made him aware of some of the things that are going on in
dentistry already, and I told him I would write to you and give you a
description of what is occurring in dentistry now with ready graphic
transmission, peri-information(?) transmission electronically, and our
relationship with the DICOM standards, our support of that standard, we’ll
write to you, the ADA will write to you and tell you what’s happening in that
area so you have some basis for looking at this. I know that your, the medical
world apparently is behind the dental world, I won’t make a smart remark, I’ll
just leave it at that. Don’t undo what’s already being done, that’s being done
successfully, in devising a system that you may ask the medical people —

DR. COHN: And we appreciate that, obviously as you know we are talking
about a hearing on claims attachment that hopefully we can get some
representation from dentistry because it sounds like you’ve got a lot of
experience.

DR. GUAY: I told Frank to track that and when that invitation comes out
we’d be happy to talk about our experiences in that area.

DR. COHN: Thank you. Dr. Adams?

DR. ADAMS: I’d just like to thank the subcommittee for supporting these
initiatives and comments, we’re looking forward to a resolution of those two
issues as well.

DR. COHN: Okay, great. Dr. Schooley?

DR. SCHOOLEY: I would just like again to echo the focus on dental, it’s
really refreshing to spend a little bit of time on dental from time to time and
I appreciate the subcommittee’s attention to that. Thank you.

DR. COHN: I would just say personally, obviously I’m not a dentist nor do I
play one on TV, my history is in medicine, but it’s actually very refreshing
and I think we’ve all learned a lot from this session. So thank you very much.

Now with that we will take a lunch break, we’ll take an hour, we’ll come
back at 1:15.

[Whereupon at 12:15 p.m. the meeting was recessed, to reconvene at 1:15
p.m. the same afternoon, January 28, 2004.]

AFTERNOONSESSION [1:15
p.m.]

DR. COHN: Okay, would everyone please be seated, we’re going to get started
here in a second.

Well, welcome back to the afternoon session. Just a bit of, I guess an
update as well as a couple of comments before we move into the afternoon
session. Now first of all I think we talked during the morning session about
needing a special session to talk about claims attachments in more detail and I
wanted to announce that we’ve identified a date for a special hearing on that,
for March 3rd, which is the day right before the next full meeting
of the national committee, so if you’ll mark that down on your calendars,
please reserve the date, obviously those on the internet be aware that we will
be broadcasting this over the internet. The session will include obviously
discussions about the claims attachment standard and other topics to be
determined based on the number of testifiers on claims attachments. So that’s
item number one.

Number two is I just wanted to take an opportunity, and obviously this is
a, we’re in the process of transition at the subcommittee, I wanted to actually
to welcome some of our new members, Judy Warren who is an associate professor
of nursing at the University of Kansas. And I obviously want to thank you for
joining us today, we know that you’ve not been sworn in officially but I think
that will be happening obviously over the next day or two. Thank you for coming
and joining us even before that happens.

The other new member in attendance is Harry Reynolds, and you’re vice
president for Blue Cross/Blue Shield in North Carolina, I have those
credentials correct, and obviously we’re delighted that you could come and join
us. And obviously we’re looking forward to having you both joining the
subcommittee and the activities and are obviously happy that you’re going to be
available for those March hearings.

Now we’ll be talking more about our department members but obviously I just
want to thank Kepa Zubeldia and Clem McDonald, and Clem isn’t even here to hear
this but obviously we’ve really appreciated your participation and involvement
in the subcommittee, I mean we’ll be talking about the full committee obviously
tomorrow, but I know I speak just for myself but I found both of your councils
to be really critical to the success of our process and you will both be
missed. Kepa, thank you very much.

Now with that we’re going to be moving into discussions this afternoon on
the e-prescribing issues as well as DIMA, and the department work plan related
to that. We’re obviously delighted to have both Jim Scanlon here as well as
Kelly Cronan. I think Jim is going to do some introductions for Kelly so I will
turn it over to you.

MR. SCANLON: Thank you, Simon, and I too would like to welcome Judy and
Harry to the committee. If looks like you’re already recruiting Simon for
members of the subcommittee, and we’re going to give them an orientation to the
NCVHS, both Judy and Harry later today I think at 4:00, so we’ll go into more
detail, and tomorrow I think you’ll actually be official.

But today we’ve asked Kelly Cronan, who’s the executive director of our
Council on the Applications of Health Information Technology here at HHS to
give a briefing on particularly the e-prescribing provisions on the Medicare
Modernization Act. The department is very busy going through the provisions and
addressing looking at how to address these, but we wanted to focus specifically
I think this afternoon on the e-prescribing provision. The statute as Kelly
will bring you through it actually contains a very specific and fairly rigorous
timeline from the point where the NCVHS makes recommendations relating to
preliminary standards, it takes us through as Kelly will point out some stages,
leading ultimately to the adoption standards for e-prescribing.

So I think I’ll turn it over to Kelly and then I think later the
subcommittee, Jeff and others, will actually talk about the NCVHS work plan.
Kelly?

MS. CRONAN: I guess I should start off by saying that we actually have not
finalized any type of timeline in terms of our implementation activities but
for the purposes of having everybody work off the same level of understanding I
think it would be useful just to highlight some of the provisions that you
should be most concerned about from your perspective.

The first date that’s most applicable is in reference to the initial
standards that the Secretary is obligated to develop, adopt, recognize, or
modify, and that has to happen by September 1st, 2005, so while that
seems like a ways off in fact the work is actually quite ambitious and there’s
going to be a lot to accomplish leading up to that. So working off that date
the NCVHS will have to provide recommendations to the Secretary and have enough
lead time for people to sort of process that information and figure out in what
way are they going to recognize, develop, or adopt these initial standards. So
that’s probably the most important thing to be aware of in terms of timing.

In the statute it does actually specify that NCVHS should consult with ANSI
accredited standards setting organizations, practicing physicians, hospitals,
pharmacies, PBMs(?), state boards of pharmacy and medicine, and other experts
on electronic prescribing. You should probably also be aware that there are
some activities in the private sector right now that are focusing specifically
on trying to get experts organized in working groups to address some issues
related to implementation and in part they are looking at standards and one of
the key people from NCPDP is involved with that effort. So perhaps in your
planning you may want to keep in mind that there are some ongoing activities in
this area and they might be able to inform your recommendations.

There is a series of other deadlines that we’ll be considering when we
start with the process of planning for a demonstration project around these
standards and then they’ll be a rulemaking process that will be going on in
parallel over the next few years. But I think it’s premature to comment on any
of that as we have not really determined how we’re going to be working with
that and it’s really not all that relevant to what NCVHS has to do.

What I think is important to point out is some of the design criteria for
these standards, that need to be considered as you put together your
recommendations. The standards are supposed to not impose an undue
administrative burden on prescribing health care professionals and dispensing
pharmacies and pharmacists. They must be compatible with what’s already been
promulgated with HIPAA, and they also must be designed in such a way so that
they enable the exchange of electronic drug labeling and the listing, which I
think in previous meetings and other activities you’ve been briefed on, this
really gets back to the terminologies around medications going to enable
structure product label, which will be disseminate through NLM.

The other important provisions to be mindful of relate to the information
that’s supposed to be going to health care prescribing professionals and
pharmacies and pharmacists, and that information includes information on
eligibility and benefits, which means information on drugs that are on any
given formulary, any tiered formulary structure or any requirements for prior
authorization. This also includes information on the drug itself that’s been
described or dispensed, as well as medication history for a given patient,
which could include information on drug/drug interactions, warning cautions and
when necessary dosage adjustments. Information on the availability of lower
cost alternatives or therapeutically equivalent alternatives must be made
available as well as requested.

Then there’s another specific provision on medical history information, and
again the date has not been specified in terms of when standards would have to
be available or observed, but the Secretary has discretion here to set that
date. But what’s important here is that again, pharmacists and pharmacies and
physicians or prescribing clinicians will have the ability to request for
medical information as needed, but it must relate to the patient that they’re
prescribing for and it must also relate to the drug or drugs that are being
considered.

A couple of things that we have been talking about internally and thinking
through some of the needs for implementation, we recognize that there’s already
some standards that are already out there, particularly NCPDP messaging
standards that are enabling electronic prescribing right now. We don’t really
understand the gaps, what are they currently covering and what more would be
needed as we think about implementing this program. We also need some guidance
on what would be necessary for the exchange of medication and other relevant
medical history information. And we also need to know what exists in terms of
evidence or standards that are already being developed or adopted in the area
of knowledge representation, that’s sort of one entire universe of standards
that really hasn’t been dealt with that much, at least internally here. So we
really would like to know more about that area, how it interacts with what we
need to be doing and I know that to a certain extent this was addressed in the
recent IOM report so that would perhaps be one point of reference in starting
to trying to get our arms around this.

So I think those are the most important considerations that we’ve thought
about so far, I don’t know if Karen Trudel has anything to add to that, who’s
also working on this.

DR. COHN: I think we’ll open it up for questions and discussion. Kelly,
maybe I’ll start off just because I was obviously looking through the
legislation and I think you’ve done a great job summarizing it. I actually
appreciated some of your comments about the application to medical history
information, which is I think the area that we in many ways had the most
question about, about exactly how this all interplays because on one hand it’s
clearly critical, the scope could be literally equivalent to an electronic
health record if one isn’t careful, and then of course you’re sort of comment,
which I think I’m hearing, is that you’re not sure whether the timeline is
necessarily the same as for the other pieces, and I guess that may be is the
question I have for you. I guess I had read through this and been assuming that
the timeline for that medical history information dependency was literally the
same as everything else. I mean what is your counsel on that?

MS. CRONAN: Well, that’s a good question and we really haven’t gotten
general counsel to advise us in this matter yet, so it’s premature to say
anything definitively. But my current interpretation of the language is that it
does say effective on or after such a date as the Secretary specifies, and it
could allow for some flexibility. But I think in terms of the NCVHS perspective
it would be preferable to have some guidance or recommendations from you so
that when the initial standards are developed or adopted or recommended that
that information could be taken into consideration earlier on.

DR. COHN: So as much as we can do in other words. Just to make sure I
understood.

MR. SCANLON: Simon, I might again, because of the complexity here, I think
whatever plans we lay out, or the subcommittee, I think we’re just going to
have to be in a mode of being able to change and expand and adapt as we get
into the area, much as we did with HIPAA and other initiatives like that where
you sort of, you started out with the scope of investigation, you look at what
exists and what are promising candidates for standards, and what’s their use
and so on. But I think other issues inevitably arise that are related in how
these all come together, and so I think the mode for the NCVHS particularly in
this first year or so would be just to be fairly flexible about, we can start
with the standards that are clearly the main focus but just to kind of keep
open I think as well as we move along.

MS. CRONAN: Yeah, and it’s important to stay in contact, HL7 might be
taking on some additional work related to data exchange with EHRs that could
end up being done in parallel with this effort and be relevant to the exchange
of medical history.

DR. COHN: I would say the scope on this one is a, I mean the first piece is
you can get your arms around, the second one, as you know it could take many
different directions. Kepa?

DR. ZUBELDIA: Is it the intention here that there would be several
standards adopted and perhaps some may have to be delayed? I’m looking at this
list where it’s not just the prescription, the electronic label for instance
has to be transmitted, eligibility, DUR, drug history, medical history, is the
intention to adopt standards for everything on the same date or whatever is
available and then wait for the industry to develop the new ones? Or is the
Secretary going to create standards for the gaps so that everything can be done
at the same time?

MS. CRONAN: Well, I think that we’re hoping that initially over the next
year or so we’re going to have a good idea of what currently exists, where the
gaps are, and where development activities need to start ASAP. And then to the
extent feasible whatever is available in terms of messaging standards,
terminologies, so that would also incorporate drug labeling, and standards for
knowledge representation, we would then, or the Secretary would then be in a
position to adopt what is available or recognized as available come September
5th.

DR. ZUBELDIA: So what’s the intention with the things that are not
available? To wait for the industry to develop the standard or to create a
standard like was done for privacy or security?

MS. CRONAN: I think that the language is intended to be flexible so that
for example if the NCPDP scrip standard is working and it’s been widely used to
date then there’s no reason not to adopt that, so it’s something that is mature
and been tested and tried and true, there’s no need to reinvent the wheel
there, but for areas that are much lesser developed that development activity
would have to be recognized and encouraged and hopefully they’ll be enough time
as we go in the next couple years to allow for completion. So it will be a mix
of adopting what’s already out there in addition to encouraging new activities
where they’re necessary.

DR. COHN: Michael?

DR. FITZMAURICE: Two questions, the first one is you mentioned a gap
analysis of what is needed between what is needed and what the scrip standard
and other standards have, and also you mentioned looking at what standards
already exist in the area of knowledge representation. Will the department be
able to share those reports with the national committee?

MS. CRONAN: I was actually meaning that we need that type of guidance from
NCVHS, to the extent that it’s feasible we will probably be doing our own
informal analysis.

DR. FITZMAURICE: And secondly, in the claims process, it’s not only
ordering the drug but there’s going to have to be a claims process as well and
imagine look at the 837 and at the NCPDP claim form, but the vocabularies
probably have to fit together. Will you be looking at what vocabularies to use
for both the claims process and the e-prescribing? We’re certainly going to be
looking at the vocabulary for the e-prescribing and there’s got to be this
harmonization between the two.

MS. CRONAN: That’s something that has been considered but if it could be
interpreted as a part of the entire program then perhaps it should be.

DR. COHN: Well, Michael, are you talking about beyond the HIPAA standards
already for drug payment?

DR. FITZMAURICE: We’ll probably have to go beyond the standards for the
drugs in order to do e-prescribing.

DR. COHN: Oh, definitely, but I think the other —

DR. FITZMAURICE: I’m talking about the compatibility between the
definitions of those variables in the terminology and what we recommend for
e-prescribing.

DR. COHN: Okay, I’m sorry, Karen?

MS. TRUDEL: I think there’s a need to make sure that three different things
are compatible, one is any e-prescribing standard, another is a standard that’s
elsewhere in the legislation where the Secretary adopts standards for a drug
card, not the drug card provision but an actual card that can be used under
Part D, and also any of the administrative transactions that would be used from
pharmacy to prescription drug plans to actually handle the eligibility, the
payment, the remittance advice. And we will need, we, amorphous we, will need
to make sure that they all do harmonize.

DR. COHN: Very good point. Jeff?

MR. BLAIR: Thank you for the guidance that you’ve given us to the extent
that you could give it at this time, but things are obviously in flux and we’ve
been struggling at the same point, we’ve developed two versions of the work
plan where we’ve tried to identify all of the requirements that you have
mentioned and try to see how we could set up a schedule to educate ourselves
and receive testimony from terminology developers, standards developers,
providers, payers, PBMs, and all of the other stakeholders that were specified
in the law. We will be after this session reviewing our second draft of that
work plan in terms of how we will be trying to look at all that with applying
priorities and timeframes and requirements. By any chance do you have the time
to be able to stay so that as we go through our work plan you would be able to
make your comments or observations?

MS. CRONAN: Yes, absolutely.

MR. BLAIR: Great, thank you.

DR. COHN: Stan?

DR. HUFF: I don’t know if we’re to the point to ask this question but can
somebody tell me what it means exactly in terms of who is eligible? It says all
of the folks, eligible individuals within the voluntary prescription drug
benefit program, what does that really mean? Is that only outpatient
prescriptions? Inpatient prescriptions? Discharge medication from institutions?

MS. CRONAN: I think it’s Medicare beneficiaries who have elected to enroll
in Part D.

MR. BLAIR: Part D meaning —

MS. CRONAN: The new drug benefit.

DR. HUFF: I’m not smart enough to know what Part D is, I’m getting closer
so maybe I should know this.

MS. TRUDEL: To answer your question, Stan, the payment for a drug under
Part D is only when it couldn’t be paid for under Part A or Part B of Medicare.
So if it could have been paid for under an outpatient hospital benefit or an
inpatient hospital benefit it isn’t a Part D drug at all. I think that’s where
you were going, so we’re not talking about inpatient within a facility, we’re
talking about primarily patient carries scrip to the pharmacy, or that’s the
traditional outpatient way to do it.

DR. COHN: But Stan actually you do bring up a very good point, and first of
all Part D I tend to think of as D stands for drugs, and that’s how I remember
it, but it’s obviously the new benefit under the Medicare Reform legislation. I
think you did bring up a good question where you sort of said geez, does it
handle inpatient, and the answer is probably no, definitely no since that’s
already a Part A covered benefit, but we’d have to actually look at the
question which you brought up which was something dispensed on discharge from
the hospital, I think we’d have to do some analysis to figure out whether
that’s a Part D benefit or a Part A benefit. And I don’t know that one off
hand, so I think you’re bringing up a very interesting question about how close
to the hospital process are we getting.

DR. HUFF: Well, I guess the other thing is that in the back of my mind I’m
starting to think already about what scrip does and where it’s used, and
scrips, typical domain has been outpatient prescription drugs and usually oral
drugs, in other words scrip doesn’t have, as I remember, I’d have to review,
but it doesn’t, for instance if we prescribe this as outpatient IV medication
I’m not sure that scrip has, so I’m just trying to figure out whether some of
those harder cases actually fall into the scope of —

DR. COHN: Well, I think that will be part of our investigation, and I don’t
think you have to figure it out right this second but you’re asking exactly the
right question. I mean because that really is part of our scope discussion and
really our investigation is to try to figure out where the gaps are and how
they can best get handled. So Stan, we’re glad you’re on the team. Other
thoughts or comments? Questions?

Okay, well Jeff with that maybe we transition to talking about the second
version of the draft work plan. I think some of you have it, I’m trying to
think whether everybody has copies of it. Harry, do you have a copy of it?
Judy, you have access to it. I would just sort of comment that as I reviewed it
I thought it was a vast improvement over earlier versions. I also really
appreciated the fact that Jeff had taken the actual legislative language and
attached it to the back so you could sort of go back and forth to see if there
were things missing, which is always very useful, it’s always very good to stay
grounded. Jeff, do you want to lead us through?

MR. BLAIR: Sure.

Agenda Item: E-prescribing Work Planning – Mr.
Blair and Dr. Cohn

MR. BLAIR: I’m just going to pause for a sec, you’ll let me know if you’ve
got a copy in front of you.

MR. BLAIR: Kelly, I don’t know if anybody mentioned to you that I happen to
be blind, so there’s going to be certain ways that I talk about things that are
going to reflect that that might otherwise seem odd but that’s the reason why.
And I don’t, I didn’t go back and memorize the work plan but let me just take
you through some of the steps. The first section basically is the outline of
the plan, where we basically indicated the statement from the law, the scope,
the statement of the law, and the law being the Medicare Prescription Drug,
Modernization, and Improvement Act, and the third statement in there that
really was kind of interesting because it’s been more directive then many of
the other directives to the NCVHS, which was quite a list of the stakeholders
that we should consult with. I interpret that meaning as receiving oral or
written testimony from.

And then that kind of gives you a heads up on that. Kelly has actually
taken us through most of those items, so that’s good, we don’t need to revisit
that. And then the next section is the work plan with the five sub-items of the
work plan, and then the last part the appendix for your reference is the
portions of the law that at least as a non-lawyer and a non-legislature I was
able to identify as pertinent to this effort. There are items, there are
references in the law to other sections and I think the first thing I would ask
for help for on behalf of the NCVHS and I don’t know whether it’s to you, Jim,
or Karen to you, or Kelly to you, but some of the other references to the law
we did our best to try to identify what they were if they were in other
portions of the Medicare Prescription Drug, Modernization, and Improvement Act,
we think we found them, but if there could be some independent verification on
those references that would help us to know that we’re not overlooking
something.

MS. CRONAN: Yes, we’ll be sure to do that.

MR. BLAIR: Now to the work plan. This is our second version, I in no way
imagine this is going to be our last version, this is work in process, this is
to sort of get us to think through where we’re going with this and Karen and
Maria have been very helpful to Simon and myself in terms of certain things
that should be reflected in this particular work plan, so I’m going to just
mention some basic assumptions that are reflected here.

And the basic assumption here is that we should have the final
recommendations to the Secretary no later then June of 2005 and that if
possible we’d like to see some interim recommendations earlier then that to the
degree that we can do so. And so this particular version was an attempt, a cut
at trying to do so. I’m a little bit nervous and that’s why I’d really like
your critiques whether we are giving enough time to all of the stakeholders,
whether we’ve included all the stakeholders, and the method to maybe test that
a little bit, is in the work plan one of the, it’s not the first or second item
but it’s identified a list of what I perceived the requirements to be. And if
there’s some important requirements, information requirements that are off of
that list it would be very helpful if we could identify those, either in this
meeting or shortly afterwards, to make sure that we’re gathering information to
reflect those requirements, the requirements for an e-prescription set of
standards.

I’m using the set of standards very broadly because that could be message
format standards or it could be what I’d call terminology standards, or code
sets, and it also could include areas of standardization which may not exist,
Kepa kind of alluded to that, there’s a lot of decision support knowledge based
standards that may not exist as national standards but may exist as standards
that PBMs use or health plans use in terms of how they construct their
formularies or private sector drug to knowledge based vendors may use, and so
that has yet to be determined.

So maybe the first thing I would ask is as you look down the list of
requirements, and this is kind of general, do you see any glaring major errors
in that list of requirements that has been left off?

DR. COHN: Jeff, are you referring to the entire subcommittee for discussion
on that?

MR. BLAIR: Or anybody here, yeah.

DR. COHN: Okay, good. Kepa?

DR. ZUBELDIA: Jeff, I have a question. On the final recommendations you
have a first draft, second draft, final draft, and the first draft says April
2004, second draft May 2004, final draft June 2005, are those years correct or
everything is 2005?

MR. BLAIR: There’s an error there, here let me back up, before I could to
the schedules could I just stick on the requirements first because I’m going to
go through the schedules and explain that a little bit more. Does anybody see
where I’ve left off a requirement?

DR. COHN: I guess maybe I’ll start out and it’s more my reflection earlier
about this issue of other medical information, or whatever, and I think what
you have here is a list that at least to my view is relatively complete for
that first requirement, which is really the support e-prescribing, I think we
just need to somehow, actually I’m just pulling out the provision for other
information to prescribing health care professionals and dispensing pharmacies
and pharmacists. And I think you’ve done a very good job on that one. I think
we need to somehow reflect this application of medical history information, and
just as I think really one of the requirements. I would suggest that we leave
that undefined at the moment and maybe that’s one of our priorities, maybe
priority, and I think we have five priorities, maybe it’s priority six to
further define that.

MR. BLAIR: Okay, actually in a sense I was figuring that we could either do
it as priority six or to some degree some of that may be reflected in, I think
I have it as priority two, which is the decision support activities where we
may have to relate to history, drug to various other health care information.
It maybe some of in both.

DR. COHN: Okay, all set.

MR. BLAIR: Anything else on requirements?

DR. COHN: Kepa.

DR. ZUBELDIA: On the requirements list you have e-prescribe messaging
standards as one entry. Does that, I assume that’s going to include refills and
is going to include response messaging standards and supplemental information
messaging standards and all of the above, right? It’s not just, because the
rest of the requirements are well detailed, like drug to drug interactions,
drug to allergy checking, drug to laboratory resource checking. But on the
e-prescribe messaging standard it looks like its everything lumped together and
there’s a lot more in that.

MR. BLAIR: That is the way I was envisioning it but I certainly can as we
go along a little but further get more detailed on that.

DR. COHN: Other comments, Karen? Michael?

DR. FITZMAURICE: I’m not sure where it might be in here, Jeff, the drug
labeling information. I think FDA has a, I don’t know if it’s a standard but
they have a way that they would like manufacturers to report that and we
probably could just incorporate that in here.

MR. BLAIR: Yeah, and that reflects the fact that I wasn’t sure how to
reflect it, I was thinking that it was going to be part of the terminology
standards because on our PMRI, core set of PMRI terminologies where we have
RxNorm and NDF-RT and the ingredients, manufactured dosage forms and product
types from FDA, I was assuming that the FDA work was going to be consistent
with the labeler identification but I really wasn’t sure, so I’m not sure
whether it’s part of the terminologies or whether that is a separate item, so I
think that’s, I think that’s a valid question.

MS. CRONAN: To the best of my understanding I think that the terminologies
will enable the structured product label, which is what the intent of the
language was, but there actually is an HL7 process also going on, a standards
setting process related to SPL that might want to be considered. And I don’t
know if it would be additive or actually could be part of what we’re
considering as terminology standards.

DR. FITZMAURICE: I think the FDA reg refers to the presentation of the
labeling information as opposed to the vocabulary within the labeling
information.

MS. CRONAN: That’s true, within the physician labeling rule there is a
section, a highlight section that could enable a certain format or a certain
type or amount of information to be communicated, which could perhaps be
perceived as part of this knowledge representation here.

DR. ZUBELDIA: Also, the requirements list doesn’t show drug history
information and I thought that Kelly said that that’s one of the requirements.

MR. BLAIR: Separate from, I thought it was when it said history that it was
patient history, you’re saying drug history? Or you’re talking about the
history of medication —

DR. ZUBELDIA: History of medications prescribed to this patient.

MS. CRONAN: It could be interpreted as a subset of medical history.

MR. BLAIR: Unless there’s another major omission there from the
requirements list would it be okay if I stepped you forward into at least the
priorities the way I grouped them, I’m not sure that these are the right ways
to do them but we certainly can consider changing these. But as I started to
look at those requirements in order to try to see if there was a way to come up
with interim recommendations I tried to see if I set the priorities and then
try to group them then that might enable us to have a set of hearings, multiple
sets of hearings, where we could come up with a logical break for interim
recommendations. So you can wind up seeing how I identified that, which is, and
I’m not going to read down the list of each of five or six priorities that I
had because I think you can read them there, but when I looked at that and then
I matched them against how we would get information about each of them it
appeared to me as if the first three priorities, it wouldn’t make sense to ask
people to come back and give us information separately on those, it seemed to
be so interdependent.

So I grouped priorities one, two, and three together because I felt like if
we have vendors who are offering information systems software to facilitate
e-prescribing, or if we look at some of the entities that are already beginning
to implement e-prescribing, there’s a number of initiatives in Massachusetts,
Rhode Island, HIMSS has a demonstration project that’s about to start with the
Cleveland Clinic, there’s several around the country that have been moving
forward, Share Scrips and All Scrips, so I figured that, so I called those
users, folks that are beginning to implement now I’ve referred to as users and
the health care information software developers I’ve called vendors. And then I
separately indicated more broadly providers that might be planning to implement
these things in the future and payers and PBMs, and I grouped them into
hearings as you wind up seeing, figuring they would be addressing those first
three priorities.

Now there’s, Simon observed that since I’m only listing the sessions for
testimony I figured there would be an additional session, not for testimony,
that would follow those three where the subcommittee would probably need to
meet by itself and pull a lot of this stuff together. Now in my mind I was
figuring that the first session would probably be March, the second one in May,
the third one would have to be a new subcommittee meeting that we would either
schedule for June or July, and then the meeting where we would pull all of this
together to begin to draft how we would do the interim recommendations on these
would probably be September now, and then the full committee would wind up
approving that in November. I’m leaving a little bit of time in there because
to be honest with you I feel as if there’s probably going to be more testimony
needed then what I’ve just identified here, and that we’re either going to need
another session in there somewhere or a follow-up session or additional
testimony. So now that I’ve kind of described that first, those first three
priorities leading to an interim recommendation on those topics in November,
let me ask you all do you feel comfortable with those priorities? Should we
change those priorities? Do you feel comfortable with the times for the
testimony? What are your opinions and feelings?

DR. COHN: I think a number of us have comments, I see Kepa, Kepa first and
then Steve.

DR. ZUBELDIA: Jeff, I would go first for the low hanging fruit. There are
certain things that are pretty much in agreement by most of the prescribing
retail pharmacies groups, for instance the use of the NCPDP scrip for retail
pharmacy prescriptions is pretty much common. Perhaps the use of the NCPDP
transactions for eligibility, since the eligibility would be done against a
pharmacy benefit plan. But there are other things that are a little more
controversial for which there’s not really well defined standards, and there’s
some things for which there’s clearly not a defined standard, like labeling, or
the medication history. And that may take a little bit longer while the
industry rallies around the standards organizations to define these standards
and by then perhaps you can get testimony when there is a brand new standard
that has been defined, so —

MR. BLAIR: [Inaudible.]

DR. COHN: — get some authorities to come in and at least give us some of
their perspective and background of what the lay of the land looks like almost
before we hear testimony from people that are using it or otherwise, which of
course just makes our work plan longer but I think you obviously observed that
you thought this was a pretty bare bones work plan. I don’t know if that makes
sense to everybody or not but I’ve seen some people nodding their heads that
that is probably a little early education might be useful.

DR. ZUBELDIA: Now that Marjorie’s not here let me ask something, can the
NCVHS hire somebody to do an inventory of standards in this area?

DR. COHN: We’re actually going to be I think engaging a consultant to
assist us with this work. Now Steve.

DR. STEINDEL: A couple of comments, some of them are in line with what you
just made Simon and with what Kepa made as well. One of the things that I see
that’s missing from the first three priorities is what’s coming out as a gray
area in my mind, and that’s the area of medical history/drug history, and how
we should handle that within the world of e-prescribing, which may not be
necessarily the same as being handled within the EHR, because essentially what
we’re doing is we’re introducing a drug benefit, what is it 2006 it’s supposed
to go live, is that correct?

DR. COHN: Correct.

DR. STEINDEL: Yeah, that’s what I recall as the date, and that’s two yeas
away and if we went for a full medical history as a requirement for
e-prescribing we’re saying that every physician in this country has to have an
EHR by 2006. I don’t think we’re in a position to even think about that, so I
think the medical history part, the drug history part, I think we need
clarification on what’s required in that area, or maybe we can provide
clarification on what can be done in that area, one or the other.

MR. BLAIR: Steve, one of the pieces on that is while the recommendations
that we have to give might be June of next year and the Secretary has to wind
up giving his report by September of next year, then there’s 2006 for the
demonstration project, then I think it’s, is it 2008, the early part of 2008
before final recommendations? So we might be able to start to lay this out in
phases or —

DR. STEINDEL: Well, I think this gets to what the main point I was going to
make, and this is in line with what Simon was talking about and what Kepa was
talking about. I would look at a first session that’s more educational, and as
Simon was pointing out sort of a lay of the land state of the art of what’s
going on there from the experts, and also not just the standard and medical
experts but a lay of the land from what the department expects as to how this
would proceed with things like history and what’s required by the law. I mean
we’ve been briefed very, for a few minutes today and a few minutes maybe some
other day, but it might be good to have a really formal session laying out what
we need.

DR. COHN: I guess I don’t want to create expectations for this session,
which will probably be in late March assuming that comes into place. I’m not
sure that I would have an expectation that the department would have complete
understanding of this area either and I think that for all of us it’s sort of a
learning area where we begin to understand what the essentials are, and so I
think it’s maybe a little bit early, and Kelly you can help us with this one,
but I don’t really expect by the end of March that you will have all the
answers to all these questions and I think that’s the point of getting the
experts in, to begin to understand what’s essential and what’s not.

DR. STEINDEL: And I think part of it would be laying out what questions
exist.

MS. CRONAN: Perhaps we could just make sure that we have a continuous
dialogue so that any questions that arise during our discussions that are
important for you to address during the hearings, we make sure that you know
that. But I just wanted to make a quick comment to address your comment about
standards for medical history. I think it’s important to keep in mind that the
more that these standards enable advanced decision support, which those
applications already exist and they are already being used, the better of we
will be and the faster that everyone will realize those benefits. So I don’t
think that we should be putting that off thinking that it’s something that’s
going to take a long time to develop and it’s not important enough right now, I
think it’s something that is really important and a certain segment of the
market is already out there using those applications.

DR. STEINDEL: And then, that’s very helpful, it’s helpful in terms of
ordering the sessions and coming forward. In terms of ordering the sessions I’m
kind of in agreement with what Kepa was talking about, and I might want to see
what you have laid out, Jeff, as your session three, as being the first meat
session, not the educational session.

MR. BLAIR: What did I say for session three?

DR. STEINDEL: That’s where you have the pharmacies, the participating
pharmacists, pharmacy benefit management, the SDOs, to lay out the scope of
what’s out there and what people are using today, and then come in with the
next session being what you had as session one, which is a demonstration
projects, etc., so we can see how what people laid out as what they think is
out there, then we find out from the people who are really out there, what
really is being used. Then I would have a more educated sense of interpreting
what the demonstration projects are.

MR. SCANLON: I think as well if we start off with kind of an overview and a
state of the art then it’s a little, at the moment other then a official
matters I’m not sure very many folks know whether there are many standards to
look at or very few, or whether they’re mature standards with a high degree of
penetration or virtually nothing, or one of a kind. So I think that overview
session kind of sets the framework for you, what are the gaps, what’s the
nature of the standards, are there competing standards, are there no standards,
are they one of a kind kind of standards that are more vendor specific. From
that point you can form a much more sophisticated and informed kind of a way of
proceeding, and again, if there are obviously low hanging fruit that would help
then they would, you could sort of sort that out. I’m afraid at the moment it’s
hard to even, I mean except for real aficionado’s I’m not sure that anyone has
a good sense now of what, in terms of national standards, what the situation
looks like.

MR. BLAIR: let me ask you this because I think several folks have said
they’d like some type of a beginning session which is an educational session,
what is the status of what’s out there, what are the gaps, and what is needed.
Now I didn’t label it that way but when I was indicating that we would pull in
the current users, the folks that are out there implementing these systems now,
that’s kind of what I thought they would be telling us, that we would script it
in terms of answering those questions, but you didn’t see it that way. Are you
thinking of folks different then those folks to tell us, so who are the other
folks besides those folks that could tell us what’s being used today, what are
the gaps, what are the standards that are needed, who should we add to that
grouping that could give us that education?

MR. SCANLON: I always like to start myself Jeff with kind of an industry
analyst approach like we did for HIPAA and for patient medical records
standards, I don’t know who the authority would be, a vendor free, I think
that’s the next stage but I sort of like an industry wide perspective on that
without any ax to grind.

DR. COHN: I actually agree, without any ax to grind I think is the critical
issue, I think if we’re listening to vendors and others who are actually using
things clearly they have made a decision and its in their vested interest that
we support their decision so they don’t have to change, I think that we have to
realize that they are going to have their own perspective. So yes, now of
course the question of finding such as you described as them —

MS. CRONAN: It might be someone within NCPDP who has been working on these
issues for quite some time, they might not be quite as well versed on all the
decision support applications but I know of at least one person who knows this
area very well.

DR. STEINDEL: It might also be helpful to check with the Congressional
staffers who helped put together this bill, if they know anyone, people that
could meet this requirement.

MR. SCANLON: It’s a lot easier to write these things.

DR. STEINDEL: Yeah, I know, I know, we were looking for sources, we were
looking for academic —

MR. SCANLON: I’m thinking it’s not even one person in terms of the
overview, I think it’s different perspectives and there are folks from NCPDP
that Kelly was speaking, but they’re industry analysis who actually follow
who’s doing what, what’s further along, they don’t have any, they’re not trying
to get you to buy their stuff and they could just give you a broader view of
how it looks. We did this for HIPAA and for PMRI and it takes a bit of
searching, and there’s no one view that is correct but I think that generally
gives you a good framework for proceeding. I’m sure we could identify vendors.

MR. BLAIR: Let me ask you this. Are there other comments or questions about
that first grouping of priorities, because I have a little bit of concern about
separating priority number four off from the first three, like I said I was
looking for some way to try to get interim recommendations to you soon, now by
doing it, by separating off the state and federal regulatory agencies and
accrediting agencies and medical oversight entities into probably the
January/February timeframe of 2005, do you feel comfortable separating them off
this way?

DR. COHN: Do you mean for the general overview or the —

MR. BLAIR: Well, that would be a second interim recommendation that might
come in March or April with the final one coming in June.

DR. COHN: Well, I may not be understanding exactly what you’re asking, I
mean I guess I saw a general overview as being a general overview and not just
limited to priority one, two, and three. But then I do think we need to cleave
up the testimony and probably the recommendations in some way shape or form,
but I may not be addressing the question you are asking specifically. Were you
asking more generally about whether once we have that overview can we cleave up
our recommendations? Or were you primarily asking about that initial overview?

MR. BLAIR: Well —

DR. FITZMAURICE: Jeff, can I take a stab at it?

MR. BLAIR: Let me try to explain, what I was thinking is that we would
gather testimony to address priorities one, two, and three, and try to be ready
to give an interim recommendation that related to those three priorities by
November of 2004. And hopefully we could meet that date because we were
deferring two other priorities areas for later testimony, the priority four,
which is hearing from state and federal oversight entities until later, and
then the e-signature subject, which we would have hearings on later. Now this
was like I say an attempt to get interim recommendations sooner, do you feel
comfortable with separating these out this way?

DR. COHN: Comments from the, Harry, your first comment.

MR. REYNOLDS: I know I’m not official but I do have a question. Are you, in
priority four are you wanting to hear from them based on how they might be able
to use the data as a byproduct of e-prescribing? Or how they would actually be
involved in e-prescribing?

MR. BLAIR: The first, but I’m not sure that that’s a proper assumption,
that was my assumption but maybe somebody here would wind up saying that that’s
not correct and we really can’t leave them out of that initial recommendation,
in which case we may have to push the initial recommendations later.

DR. COHN: And I guess I would answer that by, as I looked at this one I was
perceiving that there are state regulatory bodies that regulate how you
prescribe and limitations and licensures and all that, and I thought that’s
what that was but maybe I misunderstood. Karen?

MS. TRUDEL: I think if priority four has to do with again a form of
downstream data use it makes sense to separate it out. But if it has to do with
state pharmacy requirements, prescribing requirements, I think it almost has to
be, that input has to be part of the discussion of one through three to get the
sense of what’s feasible and what’s not feasible given existing laws and how
the world is working today.

DR. COHN: And certainly as I look at the list of testifiers planned for the
fourth priority it looks as you described it state boards of pharmacy, state
boards of medicine, other groups like that though obviously I think your intent
there was to be looking at those issues.

MR. BLAIR: Correct. Karen, would it be okay, though we can’t answer that
question probably today, but we’d probably have a revised work plan where we
could try to sort out that question, and then we could make accommodations to
the work plan based on the answers to that, is that alright?

MS. TRUDEL: Absolutely, I mean I view this as being a sort of work in
progress and Maria will work with you to update it as needed. One possibility
for getting that kind of input would be to invite those individuals to the
session, the wrap-up session after the first three hearings, where the
subcommittee will sit down and try to solidify everything that we’ve heard to
date. It might be good to have that kind of input there at that time, so you
could do that at a —

MR. BLAIR: Like in September?

MS. TRUDEL: Yes, so the first meeting would be the industry overview,
meetings two, three, and four would be to take testimony on priorities one
through three, and meeting five then would be sort of an assimilation and
feedback from regulators.

MR. BLAIR: Now, I think we’re all aware of the fact that we’re probably
going to have to add additional hearing dates, hopefully we can add enough
where the schedule doesn’t slip too much for that first interim report —

DR. COHN: Actually I think what was offering up, I understand HHS is
getting us apartments for the duration in Washington. Joke, joke.

MR. SCANLON: We’ll get you apartments in the neighborhood.

DR. COHN: Kepa, I think you were next.

DR. ZUBELDIA: If you’re going to be looking at state board and pharmacy
requirements you probably ought to consider folding priority five into priority
four, because a lot of those requirements are related to signature requirements
and documentation requirements, things like that.

MR. BLAIR: It sounds like we’ve just disappeared and we do not have interim
recommendations anymore, it sounds like we want all of the priorities —

DR. COHN: No, I think we could —

DR. ZUBELDIA: The rest of my comment is on bundling one, two, and three, so
you can have recommendations on one and two before there are any
recommendations on three because there’s probably not going to be a standard
right away for the priority three type of environment.

MS. TRUDEL: But I think Jeff’s point was the fact that we’re going to wind
up having to bring the same people back multiple times.

DR. ZUBELDIA: That’s probable.

MR. BLAIR: See, that was one of the things I was, I figured that a lot of
the questions on what message format standards are you using, the adequacy of
those message format standards, what decision, how are you doing the decision
support functions, and are there standards that you use, and other provider
issues, I was assuming that if somebody’s going to come in and we’re going to
hear testimony from them that all of that stuff is so bundled that to have them
come back three months later and then wind up separately addressing another
part of decision support or —

DR. ZUBELDIA: Not really, there’s two separate bundles in the messaging and
standards section, there’s one that is in use today, it’s implemented, that’s a
prescription standards and eligibility. They’re different standards, one is the
scrip, the other is the NCPDP standards and that’s, you can have interim
recommendations on that very easily. There’s another bundle of standards that
are yet to be developed, or either modified current standards or new standards
that are yet to be developed for this and it’s going to take a lot longer to
have recommendations on those just because of the immaturity. So I would not
bundle those two things together because then that would be delaying the
standards that are clearly acceptable today.

MR. BLAIR: Okay, then let me go back to one other piece. If we go down that
path and we fold in electronic signatures, that also is I think a fairly
substantial topic area which might require separate education, again hearing
from the vendors of those systems, the users of those systems, the folks that
are requiring legal compliance for those systems. If we start to fold that in I
don’t look upon that as just folding it in by adding an additional question.

DR. ZUBELDIA: What I meant when I said to bring that into priority four is
that if you’re going to have the state boards of pharmacy and state
representatives here, what are the state requirements for electronic
prescription, they are to also at the same time tell you what are the signature
requirements in their state.

MR. BLAIR: Oh, I see what you’re saying, okay, the e-signature is folded
into four, state and federal requirements for the e-signatures.

DR. COHN: Karen, you had a comment?

MS. TRUDEL: I haven’t thought this completely through in terms of groupings
of priorities but it might be beneficial to take a similar tack that we did
with Consolidated Health Informatics, which is that we identified a number of
domains, took one roll through, found the ones where we could adopt standards
easily, went ahead and made recommendations on those, and then the ones where
we could not adopt standards we circle back and take another shot at it. That
means you could do all the hearings at one point, at one time, bring most of
the people in just once maybe, or twice, and get a sense of for instance all of
the functionality that some of these vendors have all at one time and figure
out whether of that range of functionality perhaps the scrip is the easiest
thing to make a recommendation on now. The next thing to think about would be
addressing formularies and take it that way.

DR. ZUBELDIA: That has been very effective for CHI.

MR. BLAIR: Let me see if I understand you. We have NCPDP scrip now, and
folks are using it or a variant of it. And when you’re winding up saying that’s
the low hanging fruit, and you’re separating it from the decision support
areas, is that what you’re saying is the longer term, is the decision support?

DR. COHN: I think that’s to be investigated, Jeff.

MS. TRUDEL: Exactly.

MR. BLAIR: But Kelly’s winding up indicating that’s one of the high
priority areas, so if that falls to a second tier do you feel comfortable with
that?

DR. COHN: Well, Jeff, I don’t think we’re talking about tiers, I think
we’re talking about low hanging fruit versus things that take a ladder, and I
think it’s sort of scanning the environment, if something’s not there we could
meet, we could live in this room and it’s not going to make it happen —

MR. BLAIR: So you’re saying scan it first with the overview and the
introductions first and then we’ll wind up seeing how to divide near term into
long term. Is that what you’re saying?

DR. COHN: I think that’s what I’m hearing, though I’m not necessarily
saying that that’s the absolute way but probably it does make some sense.
Steve, you were —

DR. STEINDEL: Yeah, I’m just going to echo what’s being said, and
especially I like Karen bringing in the CHI analogy on how that was approached,
because there were, I look at it as four phases with regard to CHI. There was
the very first phase where we talked about it in terms of low hanging fruit but
you may have called it already picked fruit, it was in the supermarket and
already there and we just wrote a letter and said NCVHS already did the work.
And that was the first set of recommendations. And the second set of
recommendations when the domains were established those domains were broken up
into low hanging fruit that we felt things could be brought back fairly
quickly, and then stuff as Simon points out that we need a ladder for. And some
of the stuff we found that we needed a ladder for comes into the fourth phase
because we found even the ladder won’t reach it and we have to develop new ways
of getting to the fruit. And I think that’s a very good analogy to what’s going
on here. We don’t have a group that’s already picked the fruit, so what we
should be looking at is the first set of hearings, be it either just the
educational session, though I don’t think that would be true, but the
combination of the educational session, hearing from the standard development
organizations, and hearing from the users what we’re going to find from them is
a set of low hanging fruit and probably exactly what Kepa’s talking about, like
the scrip standard and things like that that are being widely used and
implemented now. And we can make a recommendation at that point and saying this
is what we found, this is what people are using. Also from those testimonies
that we heard during this period of time we have found the following we need to
look at further and we will come back with you over the next N period of time
with that and formulate our hearings then, our hearing schedule then.

MR. SCANLON: Successive actions.

DR. ZUBELDIA: My very first question to Kelly, is that acceptable? Because
the Secretary has to adopt or recommend or create all of these standards by a
certain date, then there is not this leeway to get everything that we —

DR. STEINDEL: I’m assuming that we would do what I’m looking at this the
first three sessions relatively quickly, in time for doing something by
September.

DR. COHN: And one needs to recognize using that analogy that sometimes the
solution to this isn’t a taller ladder, sometimes it’s water and fertilizer.
And if there’s nothing there there’s nothing there.

MS. CRONAN: I also think to the extent the early hearings will identify the
gaps, that that will obviously be all heard at the same time, and hopefully
will inspire some new standards or development of new standards as necessary.

DR. COHN: Exactly, extending the analogy on to the absurd. Other comments
or questions? And Jeff, I think what you’re hearing is a slightly different
slice on this, which is looking at all of this stuff and just cleaning off, I
mean as we find things that are obvious and there’s industry consensus we can
advise the Secretary sort of in waves as well as beginning to get agreement
that there are gaps and working with the industry to figure out how the gaps
get filled.

MR. BLAIR: Let me paraphrase it so that you can correct me if I don’t have
it right to prepare this next version, is what I’m hearing is we need a good
solid set of orientation education sessions up front, then to hear from those
folks who are implementing the standards and those folks that are developing
the standards, and the vendors, so those are four entities. And at that point
we should be able to know what the low hanging fruit is in terms of what is
being used, and what is not being used, and we should be able to make an
interim recommendation at that point. Did I hear this correctly? Yes?

DR. COHN: I think you are and I think the presenters are the same
presenters, probably in the same panels, it’s just that we’re having different
expectations of what we’re going to find.

MR. BLAIR: Okay, thank you.

DR. ZUBELDIA: And the approach of the CHI model of approach I think was
excellent to break it up into domains, if you can get some of the presenters to
actually work in those four groups that are identified in the domains and break
it up it may be very, very effective without having to —

MR. BLAIR: When you say domains in this case what are you saying? Domains?

DR. ZUBELDIA: You have for instance the drug labeling, that’s a specific
domain separate from the history of medications, which would be another very
different domain, or formulary alternatives, where the PBM has to respond,
these are the alternative choices, those are things that don’t exist today as a
standard that has been adopted and if you have experts from the PBMs and the
vendors and the pharmacy chains working with you on those domains to identify
the possibilities I think it would be a very effective approach.

DR. COHN: Okay, and I think we probably need a little more education to
figure out where exactly the domain cuts are at this point, which is something
to determine. We actually have Carol Bickford who’s standing up and would like
to make a comment, so Carol, would you like to make a comment or ask a
question?

DR. BICKFORD: Yes, sir. You have identified state boards of medicine as
being interested parties in the stakeholder discussion, you need to be looking
at other regulatory bodies for other health care providers who have
prescriptive authority, for example advanced practice nurses, chiropractors,
DOs, whatever. Physical therapy might fit into that as we’re looking at new
ways of doing health care practice, whoever has current prescriptive authority
in relation to medications or whatever you’re considering to be whatever.

Another entity that’s missing is infusion therapy, you’re looking more at
pills, but what about the infusion therapy, the home therapies that’s being
utilized for our acutely ill patients in the home setting. There was one other
thing but of course I can’t remember it at the moment, so I’ll stop with that.
Oh, alternative therapies. Thanks.

DR. COHN: Thank you for your comments and certainly the issue about making
sure that our, we cast a wide enough net on the state boards to handle everyone
who’s writing prescriptions is very significant. I think the other areas I
would sort of to me is a scope issue relating to the Part D benefit, and I
think we use that as the way to figure out what’s in and out of scope and I
actually don’t know whether infusion is a Part D benefit or whether it’s a Part
A benefit, I actually maybe should know that but I think that’s something we
need to research. And similarly the other issue is the context of medications
being provided under the Part D benefit and we sort of need to see where the
edges are on that.

MS. TRUDEL: We can provide clarification on that before we get started,
that could be part of the first session.

DR. COHN: Sure, great. Steve?

DR. STEINDEL: I have a nitty gritty question for the department, what do
they mean by standards? And I think we need a clarification on that because
generally speaking when we talk about standards we talk about nationally
accredited standard bodies and what they’ve accepted, and I think when we look
down this list we’re well aware that for that many of these do not exist.

MR. SCANLON: Actually we were talking a little bit about this today. I view
the lack of specificity as an opportunity, others view it I guess as —

DR. STEINDEL: You notice the word, I said we would like a clarification.

MR. SCANLON: Standards are standards, but I was going to suggest that part
of the committee’s deliberations include, when we get a little better handle,
sort of the criteria for what should be a standard or what might be adopted as
standard, much as we do for HIPAA and then patient medical records —

DR. COHN: And maybe to merge some of these concepts, it may be that some of
the things that we see are not standards yet and maybe part of our role is to
recommend that they get into the standards process. Because in a sense when
we’re talking about standards we’re talking about an ANSI accredited standard
and anything can get into that process, it’s just that some things have not
gotten into that yet, they may be more research vehicles or academic research
vehicles or whatever, and maybe that’s part of our suggestion, that that be
expedited in that process.

MS. CRONAN: I completely agree and I think that the statute actually
provides some parameters to follow, too, you need to be balancing the
objectives of trying to improve patient safety and efficiency of health care
with not imposing too much administrative burden.

MR. SCANLON: These would be part of the criteria and the balancing.

DR. COHN: Is there anything else, is this a new topic that you wanted to
bring up Jeff?

MR. BLAIR: Well, it’s feedback, it’s a feedback question. I think, really
this is a question addressed to Jim, Kelly, and Karen and Maria, the
subcommittee has kind of crafted a different perspective now on how we might go
forward on the work plan and I just wanted to know if all of you felt
comfortable with the way we are planning to revise the work plan.

MS. FREIDMAN: Jeff, it’s Maria. I’m fine with this, personally I really
like the idea of starting off with an educational overview simply because this
is not a homogeneous group, everybody’s in different places in terms of their
knowledge about each aspect of this, so if we all get on the same page in the
same way at the same time that would be great.

MR. SCANLON: I’m certainly comfortable Jeff, the only thing I would keep in
mind is that I think in this area particularly that the work plan will be more
or less a living document, and at any point it’s a draft and it can be refined
and added to almost at any meeting.

MS. TRUDEL: This is Karen, fine with me.

DR. COHN: I see everybody sort of nodding their heads, I mean feeling that
we’re doing the right thing here.

DR. STEINDEL: Can we comment on the location —

DR. COHN: I think Steve wanted an apartment, too. I think the other
observation about all of this is that I think there’s an intent as we move
forward to elicit testimony from the industry and other parties that not all of
it is going to be Washington centered, and I think we need to make sure that
we’re somewhat broadly inclusive of regional differences, as well as best
practices, and we just need to be aware of that because that does add some
burden I think to the support staff in terms of making that happen. There’s a
reason we typically do things in Washington because it’s so much easier for our
staff recognizing that we already have a pretty extensive burden, or actually I
guess we are burdensome because we have so much work that we’re trying to get
done, but I just think we need to include that as we sort of move forward.

Jeff, do you have other questions or other thoughts about all this? I mean
I think we’re all sort of thinking of digital signature and some of the pieces
around that as being a somewhat separate, I don’t want to use the term digital,
it’s probably electronic signature, as a somewhat separate though essential
step in all of this. Stan?

DR. HUFF: Well, one thing I was thinking about in regards to that is I
think it’s separate if you think you’re going to assign a whole message or a
whole thing, if you want to assign individually pieces inside then it becomes
tangled somewhat with the message standards themselves. So I don’t know if we
have that requirement, I was just puzzling over that in my head —

DR. COHN: Which requirement is which you mean?

DR. HUFF: Well, if we have the requirement to assign individual pieces of
something, of the message rather then just assigning the whole message, because
if you’re assigning pieces of the message then you have to have places to keep
the keys and the encrypted part separate from the data part, and it actually
gets involved in the format of the message.

MR. BLAIR: When we prepare our questions for the users initially and the
vendors initially that’s something we really need to get clarified up front,
whether the signature is imbedded, I guess is what you’re saying.

DR. HUFF: Right.

DR. COHN: As well as the standards developers somehow, they had perceived
this all working when you get into a place where this becomes an important
aspect of the whole thing, or has to be somehow accommodated.

DR. STEINDEL: Just as an offhand comment, the clinical document
architecture group of course has spent a lot of time discussing this in the new
release of CDA, not the one that’s going to be used for claims attachment,
assigning various sections, encrypting sections, various levels of signature,
because this is of course a very important thing in medicine.

DR. HUFF: I think your statement was right, somewhere up front I think,
it’s almost like so this is, instead of making four make it one —

DR. COHN: So we understand the other requirements?

DR. HUFF: So we understood the requirements for the message standards
before we adopted them.

DR. COHN: Well, I guess the question is is maybe this is something that we
try to get in our general education, and one of the questions, that might be
one of those high level as an important sort of understanding. Steve?

DR. STEINDEL: Simon, I think there are two parts to this question and what
could probably be handled very well in the informational session is the
requirement for signatures with regard to prescribing, and then maybe a tersery
comment about moving this into the electronic world, and then of course what
we’re going to be looking at more in terms of e-prescribing is how does this
move into the electronic world. But I think we need to understand the signature
requirements for prescribing.

DR. COHN: This is going to be quite a day session isn’t it, two days, well
whatever —

DR. ZUBELDIA: — move to four day meetings. On the topic that Stan
mentioned there is a lot of time that could be spent in that and that’s
something that you guys need to be aware of because there is so many different
views on how to do things. The scrip standard itself is in edifact(?) syntax,
there is one prescription per message, and the entire message can be signed
using edifact structures. So it would not effect the integrity of the message
and protect the integrity of the message and so on if the choice is to go with
the digital signature. So that’s already part of what’s known as 9735, which is
an edifact standard that covers the message enveloping. But it’s not compatible
or even similar to what the CDA does with signatures, complete different
technology.

DR. HUFF: And that’s my, it may be totally irrelevant because I think all
of the messages that I know about if you’re going to sign them in total we have
good solutions for, you can see easy solutions. But if you had to sign, for
some reason if you had to sign individual segments inside of the edifact
message there’s no provision for that.

DR. ZUBELDIA: So the scrip doesn’t have loops(?), it’s a simple linear
transaction, and it can only contain one prescription. The entire transaction
set is called edifact message and can only contain one prescription, so there
would never be a need to sign specific segments or specific parts of the
message.

DR. COHN: Until the next version.

DR. ZUBELDIA: No, no, that’s the current version.

DR. COHN: I’m being facetious, Kepa. Well, I think this is obviously
something we need to sort of be looking into and thinking about as we go
forward. Certainly I think one of the questions I think we’ll all have is, and
this has been an ongoing conversation about electronic signatures, is that when
as a nation we get serious about electronic signature it’s going to be useful
if standards organizations come to sort of a common understanding about how
best this should be accomplished so a prescribing physician doesn’t have to it
one way for a prescription, another way for a CDA document, another way for a
something that’s in a claims attachment, and on and on. But it maybe this
provides some direction or impetus because clearly we’ve been looking at
electronic signature since HIPAA, it’s just that there hasn’t been a business
case really around it up until now. So this may be a nice byproduct of that.

Other thoughts or comments? Come on Jeff, there must be something else here
that we’re missing.

MR. BLAIR: Don’t look a gift horse in the mouth.

DR. COHN: Well, I guess getting, without even trying to count up the number
of hearings we’re going to have on this one, I’ll let Jeff do that work as you
put things together, the committee does have two days of hearings at the end of
March, assuming that my calendar is right and I was already reminded that the
early part of March I had the wrong dates, but my understanding is that they’re
the 30th and the 31st, and there’s obviously business,
there’s other things that this committee does believe it or not, like the HIPAA
standards for example and the DSMO reports and all that I think we’re also
potentially planning at the same session, but I think we can certainly plan on
devoting one full day to the education and discussion around that.

And I think as we, as Jeff and I look at the other requirements and
timelines, I mean now that we have new members we can begin to query for some
additional dates going forward. I do hear that people would prefer to meet just
two days in a row as opposed to as Kepa commented three or four, but clearly
what we’re going to need to do some planning to make sure that we have enough
hearings to meet this and other to do items that we have. And we just hope that
the new members understand, the old members have sort of gotten used to this,
this is a pretty active subcommittee. Harry, it looks like you have a question.
No, okay, you know what you signed up for.

Are there any other issues, Kelly do you have any comments on this? Any
other needs?

MS. CRONAN: No, I think it was a great discussion today and I’m sure we’ll
continue to talk about this as we move forward.

DR. COHN: I’m sure about that. And I guess our hope would be is that the
educational session can be collaboratively developed so that it meets all of
our needs, which I think would be, it’s a useful opportunity hopefully to get a
lot of our questions met as well as bringing in others who need a basic world
view of all of this. So let’s make sure that we use it appropriately and take
advantage of it.

Now, with that it’s actually time for a break, so why don’t we take ten
minutes and we’ll come back for our final session before we adjourn, I think
we’re pretty much on time, I think we’ll spend probably 15 or 20 minutes when
we get back, talk about all the other things we’re supposed to be doing, and
then we’ll adjourn.

[Brief break.]

Agenda Item: Planning for Next Meeting – Dr. Cohn

DR. COHN: Okay, as I said this will be a relatively abbreviated session, I
know we’re meeting to stop in the next ten to 15 minutes. I just wanted to
thank everyone, I mean I know it’s been a tough day and a half with combination
of snow storms, snow emergencies in Washington, slush and from my view cold,
and I really appreciate the fact that everybody was able to make it and
participate, and I think we’ve made a lot of good progress, I mean the
acceptance of the CHI recommendations yesterday was I think a very significant
piece in completion of work. Obviously I think we were able to get into the
security rule and discussion yesterday, and then obviously the dental standards
this morning, which I think was a very useful conversation, and I think gives
us all pause for sort of recognition that the specialties have different ways
of doing things. Obviously this afternoon we made some significant work moving
forward in terms of our DIMA work and the e-prescribing.

Now lest we sort of rest on our laurels I do want to remind everybody that
we do have a relatively significant work plan for the rest of the year. I think
you’re all aware and especially the new members I from time to time pass out a
list that I keep, which is called Issues for the Subcommittee on Standards and
Security, and I keep sort of a running list of things that we need to deal
with, haven’t dealt with, need to remember to deal with, just to remind you
that we actually have a lot on our plate. And I will apologies, I didn’t make
copies for everybody but I will reference them as we sort of move forward.

I think we’re already seeing that we need to do more work in claims
attachments, and that sort of aligns with our tracking implementation for the
HIPAA regs, and I think we’ve identified at the very least March 3rd
as a day for us to do that, hopefully there will be an occasion to develop a
letter out of those hearings that we can take to the full committee on March
4th or 5th.

Now we also obviously have hearings on March 30th and
31st, and this will be sort of a combination of level setting in
relationship to e-prescribing, which I’m sure will take most of one day. But
then I think we also have other responsibilities related to HIPAA, and this
obviously have to do with hearing from the DSMOs regarding changes and updates
to current HIPAA standards and new standards, I think that we are at this point
expecting to be hearing from the DSMOs on that day, either the first or the
second day depending whether we do the education. The other day we’ll be
hearing from them, and this is a yearly activity, I know those of you who are
interested in the HIPAA standards will be interested to see what the DSMOs have
in the way of recommendations as we move forward. And obviously there’s a lot
of things sort of still open related to that conversation, both what they may
be recommending, how we move forward with new versions of standards, any
changes that need to be occurring to the current standards. So we’ll be
listening and talking about that with them.

I guess I’m also hoping at that point we’ll be having some time to talk
about the general topic, which is another one of our key areas, which is sort
of improving the HIPAA process. I know WEDI has been holding hearings, actually
these last couple days, on their views and getting testimony from the public
about that and I guess we’ll be hoping that they will be able to join us for
some conversations around that, which will be especially fruitful since we’ll
already have the DSMOs here to sort of talk to us. And so hopefully the idea
will be to sort of have a colloquia discussion around sort of ideas. I know
we’ve had those conversations previously, typically they tend to sort of
generate after our commonly held view that clearly we need to make the HIPAA
process more efficiently and timely, streamlined, responsive to the market,
etc., and then of course it gets to be that issue well what do we mean by that.

And we’ve not been terribly successful in our conversations of bringing it
down to reasonable actionable recommendations that don’t take legislation, that
are consistent with federal rules making processes and other things, but it may
be that they actually have some ideas that could help us in all of that. And
clearly one of my objectives this year is for us to come to a better
understanding of what improving the HIPAA process might be and making some
recommendations to the Secretary. So we’ll be starting on that in March, we may
need, and I expect that we will have additional conversations, as the year goes
on as we get a better understanding. Now I may be surprised and there may be
some low hanging fruit that we can take and immediately move into a letter but
we’ll have to see.

Now do you have questions about that in terms of that issue or objective?
These are just sort of issues that I’m sort of going down that we sort of
follow and are trying to deal with.

Obviously we’ve talked today about the e-prescribing, which is going to be
an ongoing issue for this year. We’ll be talking about it in March. The next
set of hearings after that for our new members, and just to remind our old
members, is in May on the 25th and 26th, have I missed,
no, actually that is the next session, after the April, I’m sorry, after the
end of March session, and I’m sure we’ll be diving head over heels into
e-prescribing at that point. We may have some discussions if they are not
brought up at the March meeting around the issue of code set issues, especially
as they apply to the administrative transactions. I do know and have noted the
couple of issues I know that Kepa has brought up over the time that we don’t
want to forget, which is for example use of the ICD procedural codes in the
hospital outpatient and how that all fits in with what is typically mandated as
use of CPT, things like anesthesia minutes, how those being used and are those
being appropriately used on the administrative transactions, and are there
thoughts and views on that as we move forward. We’ll obviously be trying to
balance that along with the e-prescribing as we move forward.

Now beyond that there are just a number of other issues that I’m hoping
that we’re going to be handling this year, and I guess I should inform everyone
that that is actually all we have scheduled for subcommittee hearings,
typically we do these six months at a time. Given what Jeff was already saying
about the project plan once we get the membership stabilized we’ll be querying
all of you for dates, and Jeff I think you were already thinking about
something, July, was that right?

MR. BLAIR: Either June or July.

DR. COHN: Yeah, well, we already have something at the end of May so
hopefully we won’t do another one before June given that we have a full
committee on the 16th and 17th, but we may have something
in July and then we may have something in late August, just because we know you
love the weather in Washington. Actually maybe by that time we’ll be able to go
to sites to talk to people out in the regional areas, and that may be a good
occasion given the weather in Washington during the summer.

Other issues that I have on this list here, and I will apologize, some of
this is hand written as I’ve made notes, just for your information is we’re
hoping at some point this year to have at least an update from CMS on the use
of the internet for clinical data, and I think that that’s been something that
we need to somehow, as we talk bout all of these other pieces, talk about
claims attachments, as we talk about everything else, I think an update to
understand their current policy, their work to figure out if there is really
applicability for them in terms of the internet would I think make sense, I
think it’s a useful conversation just to check in to find out where CMS is only
because it may effect some of our recommendations going on into the future.
Clearly we’ll want to come up with standards and approaches that work for CMS
as well as everyone else in the industry.

Now that’s sort of what I have on my to do list. Oh, and I actually forgot
CDA as another aspect of PMRI, we were going at some point need to be talking
with the groups working on clinical data architecture, as well as the
continuing care record to get a slightly better idea, not so much from a claims
attachment view though it may be timely at some point to hear from them in
relationship to that just because claims attachment does propose using CDA and
we probably ought to talk about CDA as CDA as opposed to just claims
attachment, but also understand how that relates to the continuing care record
and all of that.

As I said these are just items that we need to weave through the year.
Steve and then Maria.

DR. STEINDEL: Three things, Simon, first is very simple. Are we going to
have a session during the March full committee meeting, a two hour session as
well?

DR. COHN: Yes, I understand we do have a breakout session in March.

DR. STEINDEL: Any idea what’s going to be covered there? Okay, we’ll play
it by ear. The second is when you were mentioning internet and CMS you used the
words clinical data, do you also mean claims data?

DR. COHN: Yes, actually I do.

DR. STEINDEL: I wanted a clarification on that.

DR. COHN: I probably actually do mean claims data on this, but I guess I’m
talking about patient PHI over the internet is really what I’m referring to,
which is obviously, as in clinical data but it’s really within the claims
message.

DR. STEINDEL: And the third is one thing that I feel, and I don’t know if
it should be at this subcommittee or the NHII Workgroup, but of course we’re
all aware of the tremendous amount of work that’s being done right now on the
electronic health record and establishing standards for that, and I fully
believe that NCVHS needs to be addressed on the work that’s being done there,
if nothing else for informational purposes.

DR. COHN: I’m trying to think of when that goes up for ballot, I think it’s
actually out right now.

DR. STEINDEL: No, it will be coming out for ballot in March.

DR. COHN: Okay, so do you think that that’s something that we should try to
do either on our pre-day or during our breakout, asking for an update?

DR. STEINDEL: If it’s appropriate for this subcommittee, yes. I think it
needs to be done this early spring, yes, but whether it should be here or with
the NHII Workgroup, or even at the full committee, but we may want to talk to
John about that. But I do believe that’s something we should put on our plate,
we being the NCVHS.

DR. COHN: Mike?

DR. FITZMAURICE: There’s also a lot of standards work being done by
e-health initiative and others, we may want to schedule a session just to get
reports from those groups to see if they’re doing anything that would help us.
I know that e-health initiative is doing work on e-prescribing and so we need
to touch base with them and at least learn what they’re doing and reach out to
them.

PARTICIPANT: They’re on my list for actually one of the expert groups to
come in and give us kind of a lay of the land thing.

DR. FITZMAURICE: But there’s also like NAHIT, the HIMSS group, there’s a
lot of groups that are doing work that touches what we’re doing and overlaps
some of what we’re doing, so we need to know what they’re doing at some point.
I don’t think that is more important then our e-prescribing hearings that we’ve
set up already.

DR. COHN: Okay. Maria, what have we forgotten?

MS. FRIEDMAN: CHI, how could you forget? I thought Steve was going to
address that.

DR. COHN: CHI, that’s right.

MS. FRIEDMAN: Maybe he was trying to fly low on the radar —

DR. STEINDEL: I was trying to fly underneath the radar.

MS. FRIEDMAN: I think we have one more group that needs to come forward,
they were scheduled for —

DR. STEINDEL: No, the way I understand it, Maria, they have decided not to
report on history and physical and multimedia on phase one. Karen, you’re here
so why don’t you —

MS. FRIEDMAN: We’re talking about planning for the next meeting, the
question is what about CHI.

MS. TRUDEL: You’re absolutely correct, Steve, we’re not going to wait and
come back, we’ve decided that we’ll just not make a recommendation this time
around. We’re probably going to be spending the next four months or so
internally trying to figure out what our next steps will be, what our next
phase will look like, what gaps we have to fill, and that that’s going to be a
lot of internal discussion both within HHS and within the CHI Committee, so I
think you’re probably safe to let that one go for a few meetings, and when we
get finished we can come back and present what we have tentatively come up with
for phase two and get your input at that point.

PARTICIPANT: — looking at late summer —

DR. COHN: Like may probably.

MS. TRUDEL: Mid summer, early to mid summer.

DR. COHN: Okay, that’s great. Obviously I’ve neglected to mention security,
and obviously we’ll be following them along them this year and John Paul my
apologies for not. We appreciate John Paul’s involvement here, it’s very clear
from all of our conversations that we need to figure out some way to deal with
security in a way that is focused on security, and I know that, we really
appreciate your involvement but I also realize that that’s why you’re here as
opposed to everything else and so we’re really going to have to figure out over
the next months, I’ve said this privately but I want to say it publicly, the
best way to handle tracking and identifying issues around the security rule,
and I think that will be a discussion we have with the new committee members
about their interests and focuses and all of that and whether we continue to
have it focused here, have some sort of a bridging with Privacy and
Confidentiality, or how really how best to cover that in the most efficient
way. Comments?

MR. HOUSTON: I don’t want to mess your quorum up by having to not come to a
thrilling CHI or whatever other topics might be only on the agenda, I’d hate to
mess up your quorum if I didn’t happen to come.

DR. COHN: John Paul we appreciate that.

MR. HOUSTON: I’m a team guy.

DR. COHN: It’s okay, but I think we just need to do what makes the most
sense for the full committee and to make sure that the area is being well
covered as we move into the last year of implementation. Michael?

DR. FITZMAURICE: Simon, I was thinking. I made the suggestion about hearing
from these other groups about where they overlap with us but that might also be
a topic for the NHII Workgroup and maybe something we want to do jointly with
them, and if they want to volunteer some of the time it might not take away
from our time. It’s a potential for outreach and may have some efficiencies for
both of us.

DR. COHN: So basically we’re talking about a joint NHII/Subcommittee on
Standards and Security discussions with other groups —

DR. FITZMAURICE: Have them report to us what they’re doing.

DR. COHN: Well, that might actually be even a full committee item for
discussion, which might be sort of interesting.

Now I’d ask new members to obviously not be shy if there’s anything we’re
missing, particular interests or passions that you feel that we need to be
addressing this year, and as I said I do apologize because I’m not giving you a
copy of this, this is typically sort of my notes and I’ll clean it out and send
you both out copies via email. But we just as I said try to keep track of all
of the issues and try to slot them in to the appropriate hearings so that we
can make the appropriate monitoring or progress of all of this. Anything else?

Well, I think everyone should expect, once I said, once we get the
membership stabilized, which I think we’re on the cusp of, that you are going
to be seeing a lot of potential dates coming out for hearings in the last half
of the year because I think we really do need to make major progress on
e-prescribing and being well along our way by the probably the November
timeframe, which is what Jeff I think you were sort of alluding to also,
because even once we have all the hearings those of you who are new will
appreciate that it’s one thing to get information in from everybody but we
really need to have time to sit and talk about it and put it together into some
sort of a conceptual whole, and that in this area will not be an easy task I
don’t think.

Obviously some of the stuff is going to be low hanging fruit and we’ll be
able to create easy recommendations on all of this, but a lot of the other
pieces are going to be trying to even figure out how to properly describe and
conceptualize them will be I think some work. We’ll obviously be looking to
have, we will have a consultant in on this project but even still the
consultant can only really help reflect on what we’re coming to on the basis of
our own expertise.

Now I should ask for the new members, do you have any questions? You wonder
what you got yourself into?

MR. REYNOLDS: Simon, what I did think was important was what Michael just
mentioned, is the whole idea if you sit and listen to the different things that
are going on how, like if you take NHII, which is supposed to be the
information infrastructure, and then you talk about e-prescribing, that sounds
like an information infrastructure of some type also.

DR. COHN: You mean how we all work together?

MR. REYNOLDS: Yes, so those are going to be the things that as you watch
each of these things go forward, when you’re talking about connecting doctors
in hospitals and others together, you hope it’s one reasonable path, you hope
it’s one continuous, a discussion so it doesn’t matter whether the doctor is
checking on a prescription or checking on somebody that he’s got admitted in
the hospital or checking with a pharmacy on this or doing that, but that same
kind of infrastructure, and then when you talk about what CMS is doing with the
internet, it kind of is the simplest of all infrastructures for all of us to
hook into philosophically. The main thing is that somehow they have to tie
together because you don’t want to do it three or four times. So that will be a
thing as a new member, that’s something I am very anxious to hear to make sure
that I understand how many of these we are or aren’t creating.

MR. BLAIR: You probably would want to try to see if you could attend
February 18th, the NHII meeting here, because Bill Yasnoff and his
staff will be providing to us a first cut at a series of models, architecture
standards, legal models, as to what the NHII should look like seven to ten
years from now and the roadmap to get from where we are now to there. And NCVHS
will then wind up making our comments and contributions on those with the idea
that they would then be introduced to the public in June of this next, well,
this year, to get wider critiques on that.

And in our discussions of having that pull together part of those
discussions was virtually a rough laundry list of a lot of projects, some of
them federal government initiatives like the Medicare Prescription Drug,
Modernization, and Improvement Act with the e-prescribing activities, but some
of them were standard development activities, some of them were HIPAA, some of
them were the e-health initiative, on and on and on, and how do all of these
entities fit in. So I think that that meeting will be —

DR. COHN: I think that’s a good point, I think you need to be aware that
obviously we’re all sort of interlocked and all working together and I think
the intent is is that there really be an NHII, not a bunch of disparate
projects or activities. I think we move forward with sort of the comfort of
having the overall concept and framework in our minds and clearly in all of
this and in any of the documents that you would look at would see sort of
standards as enablers.

And so it’s one thing to have the broad umbrella concept but to obviously
move forward you need to put building blocks that are really specific in place,
and the HIPAA standards are key enablers, e-prescribing is going to be an
absolutely critical infrastructure, the PMRI recommendations, once again just
another piece of the wall or the arch that we’re creating. And once again not
from multiple different NHIIs, but really sort of how we put all of this
together in a way that it all works.

And certainly I think that that’s the vision that we all hold. So I mean
even though we may not talk a lot about the NHII here that’s only because we’re
sort of aware that we have all this super structure and we know that we’re
putting all the blocks in place to make it all happen. I mean CHI work is yet
another set of the key pieces and if at the end of the day the stuff doesn’t
all fit together we have done something way wrong, and I don’t think any of us
are thinking that we’re doing anything wrong at this point.

So I mean it’s a question of whether you start from the top or whether you
work up from the bottom, the truth is you’ve got to work in both places. And I
think we’ve all been aware that you can spend a lot of time talking at a very
high level and not get, I mean there’s comfort to you but unless you get all
the pieces in place you don’t have it. But yes, I think you will find some
comfort as we talk more about the NHII.

I think it isn’t our big concern but certainly in all this as you know the
federal government and legislative process has a way of helping set priorities
on sometimes what the next piece of rock is in this structure. And
e-prescribing is not something that we stated was the next time, though I do
have to say there was certainly a lot of wisdom in taking that on as the next
big piece because it’s really the cornerstone for a lot of patient safety and
is really sort of, it’s not the next low hanging fruit because I think we’ve
grabbed a lot of low hanging fruit, but it’s the first step up on the ladder. I
mean I really can’t think of a better choice for them to have us be working on
and moving forward on.

But you’ll have to judge on that one, I mean you may notice that there’s a
lot of holes as we move forward and we’d appreciate your insight on that. But
yes, I think obviously this is going to be a year where we’re all going to need
to be working together, there’s going to be a lot of work to be done both at
the high level and the low level, I think everyone will be involved in a lot of
it.

I want to thank you very much for a very productive day and a half.

DR. STEINDEL: Just to make a quick comment, if you notice Marietta handed
out to the subcommittee the draft CHI letter that will be handed out and
discussed at the full committee meeting tomorrow.

DR. COHN: And if you haven’t read all of it and memorized it by heart —

DR. STEINDEL: Yes, they’ll be a quiz on it at dinner tonight.

DR. COHN: Okay. We’ll go over it tomorrow but these are more along the
lines of our recommendations in relationship to the CHI recommendations, and
overall we’re concurring or in some cases trying to improve their
recommendations. So well, we’ll talk about that more tomorrow. Any final
thoughts?

DR. STEINDEL: Do you know the plans for dinner for those who will not be at
the 4:00 session? Does anyone?

DR. COHN: Well, why don’t we adjourn the meeting and then we can talk about
that. Okay, well with that I think the meeting is adjourned and thank you very
much for your participation.